Active Clinical Studies

Active Clinical Studies

The Digestive Disease Clinical Research Unit is currently conducting clinical research projects.

For more information about enrolling studies in the Digestive Disease and Surgery Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

Get Involved!

To enroll in a clinical study, call 216.636.5340 or email DDI-Research@ccf.org.

Digestive Disease Clinical Research Unit is actively enrolling clinical trials in the following areas:

The Short-term Implications of Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer on Anal Physiology and Fecal Incontinence
Tracy Hull, MD

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
Bret Lashner, MD

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of Clostridium-difficile Infection (CDI) in Adults Who Have Received Antibacterial Drug Treatment for Recurrent CDI (RCDI)
Bret Lashner, MD

An Open-label Extension of Study SERES-012 Evaluating SER-109 in Adult Subjects with Recurrent Clostridium Difficile Infection (RCDI)
Bret Lashner, MD

A Multicenter, Randomized, Doubleblind, Placebo-controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn’s Disease Who Failed Prior Biologic Treatment
Bret Lashner, MD

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
Bret Lashner, MD

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebocontrolled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
Ezra Steiger, MD

A Randomized, Double-blind, Placebo-controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-bowel Resection
Conor Delaney, MD, PhD

Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Nonalcoholic Fatty Liver Disease (NAFLD) Database
Arthur McCullough, MD

Cleveland Clinic Inflammatory Bowel Disease DNA Bank
Jean-Paul Achkar, MD

Barrett’s Esophagus Study Trial (B.E.S.T.)
Prashanthi Thota, MD

Genetic and Environmental Determinants of Barrett’s Esophagus and Esophageal Adenocarcinoma
Prashanthi Thota, MD

Mechanisms that Predict Weight Trajectory after Bariatric Surgery: The Interactive Roles of Behavior and Biology
Leslie Heinberg, PhD

A Phase 3, Randomized, Doubleblind, Placebo-controlled, Parallelgroup, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
Scott Gabbard, MD

Treatment Use of Domperidone
Scott Gabbard, MD

Limited Access Protocol for the Use of Oral Cisapride in the Treatment of Refractory Gastroesophageal Reflux Disease and other Gastrointestinal Motility Disorders
Michael Cline, DO

Muscle Loss in Alcoholic Liver Disease
Srinivasan Dasarathy, MD

Randomized Comparison of the Impact of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid vs. Polyethylene Glycol Bowel Preparation on Inpatient Colonoscopy Quality Parameters
Carol Burke, MD

Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis
Carol Burke, MD

A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Carol Burke, MD

A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery
Scott Steele, MD

Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer
Scott Steele, MD

Cleveland Clinic Florida

Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer
Dana Sands, MD; Steven Wexner, MD

Carbohydrate Loading in Elective Same-day Surgery
Raul Rosenthal, MD

A 12-week, Randomized, Doubleblind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis (RLMMD-02)
Alison Schneider, MD

Multicenter, Semi-blinded, Randomized, Controlled, Parallelarms Clinical Study on the Performance of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen (CEA) Monoclonal Antibody, for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Curative Surgery for Colorectal Cancer
David Maron, MD

A Randomized, Double-blind, Placebo-controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-bowel Resection.
David Maron, MD

A Phase 3, Randomized, Doubleblind, Placebo-controlled Study Evaluating the Safety, Tolerability and Efficacy of GS-9674 in Non-cirrhotic Subjects with Primary Sclerosing Cholangitis
Bobby Zervos, DO

A Phase III, Randomized, Doubleblind, Parallel-group, Placebocontrolled, International, Multicenter Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC), for the Treatment of Complex Perianal Fistula(s) in Patients with Crohn’s Disease Over a Period of 24 Weeks and a Follow-up Period Up to 52 Weeks. ADMIRE-CD II Study.
Giovanna da Silva, MD

For more information about enrolling studies in the Digestive Disease and Surgery Institute, please call 216.636.5340 or email

Registries & Databases

Registries & Databases

Pelvic Floor Dysfunction Database

2007

The purpose of this database is to collect medical, surgical, demographic and quality of life information on patients that are seen at the Cleveland Clinic, Department of Colorectal Surgery for a diagnosis of pelvic floor dysfunction. This would include multiple diagnoses that had to do with Pelvic Floor Dysfunction. This would include, Fecal Incontinence, Rectal Prolapse, and Constipation.

Colon and Rectal Cancer Database

1998

The purpose of this database is to collect pre-op symptoms, diagnosis, surgery, pathology reports, QOL, treatment and recurrence of patients diagnosed with Colon and/or Rectal Cancer. Patients are also asked to consent to tissue and blood banking.

Laparoscopic Database

1991

The Laparoscopic Colorectal Surgery Database is a database designed to capture the quality of life data of patients undergoing laparoscopic surgery. The Laparoscopic database collects data on demographics, surgical treatments, and preoperative and postoperative quality of life questionnaires.

Pelvic Pouch Database

The purpose of this database is the collection and storage of medical, surgical, demographic and quality of life information gathered from patients at the Cleveland Clinic who are undergoing Pelvic Pouch surgery to assess short and long term quality of life, health and functional status of these patients. Data is collected through a series of preoperative and postoperative questionnaires as well as chart review.

Diverticular Database

2004

The purpose of the registry is to better understand diverticular disease, how patients with diverticulitis manage the disease through surgery, and how diverticular disease impacts a patient's quality of life. We collect medical, surgical, demographic and quality of life information for a year.

Ripka Family Database for Crohn’s Disease Research

The purpose of this database is to collect medical, surgical, demographic and quality of life data on patients with Crohn's disease and to research into the cure and reasons for relapses of the disease. All patients with a diagnosis of Crohn's will be asked to participate in this long-term research.

Familial Adenomatous Polyposis Database

The David G. Jagelman Inherited Colon Cancer registries goal is to prevent death by providing the best care to patients and families, to promote knowledge of the risk and implications of a family history of colorectal cancer, and to produce important research in areas of concern. Data is collected from electronic, paper or outside medical records and entered into an password secured database.

Colonoscopy Database

The Colonoscopy database is a collection of medical, demographic and procedural data extracted during the colonoscopy procedure.

Familial Pancreatic Cancer Surveillance Registry

The main purpose of this registry will be to gain a better understanding of the outcomes of patients who undergo familial pancreatic cancer (FPC) surveillance. We collect clinical, endoscopic, and histological data (obtained for purposes of clinical care) on patients evaluated for FPC surveillance in a prospective registry.

HALO Patient Registry: Ablation of Barrett’s Esophagus

The research study is open to persons which have been diagnosed with Barrett’s esophagus, a pre-cancerous change to the lining of the esophagus due to acid reflux. Participants will be asked to undergo an endoscopy to evaluate the lining of the esophagus. (This is done by passing a flexible tube with a camera down a patient’s throat, while she or he is under sedation.) Areas that show evidence of Barrett’s esophagus and dysplasia will be treated with the HALO device during the endoscopy procedure. Patients will be asked to return to the Cleveland Clinic every 2 months for follow-up endoscopies, to allow the physician to monitor healing in the esophagus. Once a biopsy sample confirms that the Barrett’s esophagus has been eliminated, patients will have yearly visits that will include endoscopy (with biopsy) for surveillance. This study is open to persons who are 18 years of age and older, and who are able to give informed consent. This study is also open to patients who have been previously treated with the HALO device for Barrett’s esophagus.

Cleveland Clinic Barrett’s Esophagitis Registry

The registry has two primary roles. The registry has a clinical service role as it is utilized to generate patient reminder letters for surveillance procedures. It also serves as a potential source of patients for all Barrett's esophagus research at the Cleveland Clinic. All patients are entered into the registry based on the information derived from a data sheet which is completed at the time of the endoscopic procedure.

The Cleveland Clinic Foundation Inflammatory Bowel Disease DNA Bank

The purpose of this database is to study the genetics that cause Crohn’s disease and ulcerative colitis. Patients and a significant other are asked to donate 2 tubes of blood and answer a brief questionnaire.

Adenoma Registry

1987

The purpose of the registry is to collect patient information and procedural and pathologic results of lower endoscopic procedures done on Cleveland Clinic Foundation patients. This data can be used to address risk factors for colorectal neoplasia, proper surveillance intervals and is used to send a recall letter to patients to advise them when they are due for their next colonoscopy according to national guidelines.

Laparoendoscopic Treatment of Gastric Stromal Tumors

The purpose of this database is to collect data on patients presenting with gastric stromal tumors that have surgical intervention with a laparoendoscopic procedure.
The data is collected from the electronic chart and hard copy medical records. Information regarding symptoms, diagnostic work up, post operative surgical course and follow up contact regarding symptoms and surveillance is collected.

Pancreatic Cystic Neoplasm

This purpose of this database is to identify trends in patients presenting with pancreatic cysts and looking at standard of care testing for diagnosis and treatment.. A mail out letter and phone script are used to follow up with patients inquiring on symptoms and continued surveillance of pancreatic cysts by CT scan.

Comprehensive Liver Cancer Database

The purpose of this database is to collect medical, surgical, non-surgical treatments and surgical and non-surgical outcomes of patients with primary liver cancer.

Liver Donor/Recipient Outcomes Database

To have an organized method to access the outcomes and characteristics of liver transplant patients. This database will allow the filtering of data to answer a particular question, review the data for quality management, and observe trends including survival curves based on, for example, recipient diagnosis, MELD score at the time of transplant, etc.

For more information about enrolling studies, databases and registries in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

FAQ

FAQ

Why Participate?

Patients taking part in DDI clinical research studies at Cleveland Clinic are seen by a team of expert doctors, nurses, technicians, and support staff. Clinical research patients often are first to receive promising new treatments before they become available in the community.

Patients are helping others with the same disease, both today and in the future.

What are the Risks and Benefits?

It is important to understand that some risks are involved in clinical research, just as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time.

Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study.

Before deciding to participate, you should carefully weigh these risks against possible benefits. You may or may not receive direct benefit for yourself and your condition as a result of participating in research, but in either case, you will know that the knowledge developed may help others.

What is the “informed consent process”?

Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (providing additional information) continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study.

Translation or interpretive assistance can be provided for participants with limited English proficiency. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information.

The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract.

Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.

Who supports clinical research studies?

Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs. Trials can occur at sites as varied as hospitals, universities, doctors’ offices, or community clinics.

How are studies designed?

Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:

  • Who is eligible to participate in the trial
  • Details about tests, procedures, medications, and dosages
  • The length of the study and what information will be gathered

A clinical study is led by a principal investigator, who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

What Are the Main Types of Clinical Trials?

Clinical trials are conducted in "phases." The trials at each phase have a different purpose and help researchers answer different questions.

Phase I trials—Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.

Phase II trials—The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.

Phase III trials—The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials—After a drug is licensed (approved by the FDA) or treatment is launched, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use. These long–term studies involving large groups of participants continue to see if any unexpected side effects occur in a small percentage of individuals.

What happens when a clinical research study is over?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.

What should I consider when deciding to participate?

It is important that patients be well informed and feel confident and secure about participating. Before deciding to participate, you should talk with your own doctors, family members, and Digestive Disease Clinical Research personnel.

Be sure you know the answers to the following questions before you make your decision:

  • What is the purpose of the study?
  • What is required of me?
  • What is my role in the study—am I a healthy volunteer or a patient volunteer?
  • Will the study directly benefit me?
  • Will the study benefit others?
  • Are there risks? If so, what are they and what are the chances that they will occur?
  • What discomforts are involved?
  • What is the total time involved?
  • Are there other inconveniences?
  • Have I discussed participation in the study with those who are important to me, such as family and friends?
  • Do I wish to participate in this study?

For more information about enrolling studies in the Digestive Disease Institute, please call 216.636.5340 or email DDI-Research@ccf.org.

Why Clinical Research

Why Clinical Research

"Our vision is to advance quality research that will generate innovative treatments in digestive health and improve patient quality of life."

Clinical research is medical research that involves people. Individuals volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose and understand human disease. There are strict rules for clinical research, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration.

Clinical research studies can be a means of developing new treatments and medications for diseases and conditions or a way to track information about medical conditions over time.

Ideas for clinical research often originate in the laboratory or patient-care settings. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

Clinical research studies in the Digestive Disease and Surgery Institute fall into two basic types of projects. The first type is clinical trials. In clinical trials, a new drug or device is often being evaluated. Some clinical trials involve promising new treatments that may directly benefit patients.

The second type is an outcomes research database or registry. In a research database, information about an individual and his/her health is collected over a period of time. Research databases may indirectly benefit patients as trends about health conditions and best treatment options are identified.

Structure & Personnel

Structure & Personnel

"Improving Lives One Study at A Time"

The Digestive Disease Clinical Research Unit (DDCRU) facilitates clinical research activity for the following clinical disciplines: Colorectal Surgery, Gastroenterology and Hepatology, Liver Transplant, Hepatobiliary, Enterostomal Therapy and Nutrition. The DDCRU is an integrated multidisciplinary team of over 40 clinical research personnel.

With experience in surgical and medical clinical trials as well as database and epidemiological studies, the DDCRU offers diverse expertise within the field of clinical research.

The clinical trials branch of the Digestive Disease Clinical Research Unit are project team based, allowing studies to be conducted by a subset of research personnel with specific expertise.

Currently in the DDCRU, our clinical trials project teams are:

  • Device and Surgery
  • Endoscopy and Capsule
  • Hepatology
  • Inflammatory Bowel Disease and Nutrition
  • Liver Transplant and Hepatobiliary

In addition to experience with various types of clinical research, the DDCRU facilitates budget and contract negotiation and institutional and federal regulatory compliance.

For more information about enrolling studies in the Digestive Disease and Surgery Institute, please call 216.636.5340 or email DDI-Research@ccf.org.