Research & Innovations

A Randomized Controlled Trial to Compare the Functional Outcome and Quality of Life of Patients with Low Rectal Cancer who Undergo a J Pouch or a Side to End Coloanal Anastomosis.

Massarat Zutshi, MD

For patients with low rectal cancer requiring an abdominal proctocolectomy (surgical removal of the rectum together with part or all of the colon.) This study will compare bowel function and quality of life after surgery, comparing 2 surgical procedures (the J pouch or side to end anastomosis) which are used to join the colon and rectum. Patient participation will last about 2 years.

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal. (IMPROVE – Ileostomy Reversal)

Jon Vogel, MD

For patients scheduled to undergo surgery for ileostomy reversal. The main purpose of this study is to assess the total amount of pain medications used following surgery, and to determine if overall hospital costs can be reduced when using the study drug. The study drug will be injected into the surgical incision at the end of surgery while you are still asleep. It is thought that the timed release of medicine may provide prolonged pain control after surgery. Patient participation will end 30 days after surgery.

A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection versus Open Resection for Rectal Cancer

Luca Stocchi, MD

For patients who have rectal cancer which can be removed with surgical resection, who are undergoing chemotherapy and/or radiation therapy. This study will compare safety and effectiveness of the two types of surgery currently used for rectal cancer (Open Laparotomy Resection and Laparoscopic-assisted Resection.) Patients will be randomized to one of the 2 surgery groups. There are 15 study visits (including surgery), and patients will be followed annually for 5 years after surgery.

Timing of Rectal Cancer Response to Chemoradiation

David Dietz, MD

For patients who have been diagnosed with rectal cancer that has extended through the rectal wall (Stage II) or involves the lymph nodes outside the rectum (Stage III).

The aim of this study is to determine the best time to perform surgery in relation to chemotherapy and chemoradiation (chemotherapy and radiation given at the same time). We believe that by extending the interval between chemoradiation and surgery, and by giving the chemotherapy before surgery, there may be a greater chance that the existing tumor will disappear completely by the time of surgery. Patients will participate from the day of signed consent until 30 days after surgery (about 7 months total) with annual long term data collection (such as post-op therapy and disease status) recorded for up to 5 years following surgery.

Post-market Clinical Evaluation of the Spiracur SNAP™ Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

Michele Loor, MD

For patients with acute wounds such as post operative wounds, trauma wounds, pressure ulcers, and colostomy take-down sites. The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. This is an FDA approved device for patients who would benefit from a suction device dressing system. Comparison to patients with acute wounds previously treated will also be done, and clinical outcomes and complication rates will be evaluated. Patients will receive the SNaP® Wound Care System for up to 12 weeks, and will be in the study until the wound closes or week 12, whichever comes first.

A Randomized Controlled Trial to Compare the Efficacy of a Biological Implant, Biodesign (TM) Surgisis (R) Tissue Repair Graft, to Reinforce an Overlapping Sphincter Repair versus Standard Overlapping Sphincter Repair

Massarat Zutshi, MD

For patients who have previously been diagnosed with fecal incontinence (leakage of stool) and are scheduled to receive surgery to treat this condition. The purpose of this study is to see if placing a COOK® Biodesign™ Surgisis® Tissue Graft around the anus during surgery is more effective than repairing the anal muscle alone. Surgisis is a porcine derived piece of sterile tissue manufactured by Cook Medical Incorporated. Patients will complete a bowel diary and several questionnaires both pre and post op and will be randomized to one of two study groups (with mesh or "standard of care") before surgery. Patients assigned to the “standard care” group will receive the procedure as their doctor would normally perform the surgery. Patients assigned to the “Biodesign” group receive a piece of the Biodesign material. All other procedures and follow-up are completed as usual. Patient participation will last 24 months from the time of surgery. After discharge from the hospital, there will be 3 office visits over 2 years (standard of care visits at about 6 months, 12 months, and 24 months.) Patients may find out which group they were in upon completion of the study.

An Investigation of the Treatment of Fecal Incontinence using the TOPAS Sling System for Women. (TRANSFORM)

Massarat Zutshi, MD

This study is designed to measure the efficacy of the TOPAS Sling System , a permanent mesh that is surgically implanted with the goal of treating fecal incontinence in women. Patient participation will last approximately 39 months (9 study visits) including the completion of screening interviews, pre and post op bowel diaries, quality of life questionnaires, and follow up visits. All costs associated with the study are covered by the study sponsor. Please note that the TOPAS Sling System is not yet FDA approved for the treatment of fecal incontinence.

A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients with Chronic Constipation

Massarat Zutshi, MD and Vernon Lin, MD, PhD

For patients who have been diagnosed with chronic constipation. The purpose of this study is to evaluate the effects of Functional Magnetic Stimulation (FMS) on gastrointestinal (GI) motility in patients suffering from constipation due to non-neurological issues. FMS is relatively painless and can be applied over patient’s clothing. Patients will have SmartPill testing (to evaluate GI motility), Anorectal Manometry Testing (to measure pressures and electrical activity of the anal sphincter muscles), and will fill out questionnaires. Patients will be randomized to receive either FMS for 5 weeks or sham FMS for 5 weeks (at 5% intensity to induce some sensation but no muscle movement). 20-minute stimulation will be applied 5 days a week for 5 weeks. Patients who undergo a sham will be evaluated after 5 weeks and may be offered FMS for 5 weeks. Participation in this study will about last ten weeks total (30 visits).

Barrett's Esophagus Study Trial (BEST) 2

Prashanthi Thota, MD

For patients who have been diagnosed with Barrett's esophagus (BE) and have undergone endoscopy procedures. This study will not impact clinical care. Patients will be sent a letter and questionnaire, with a follow up telephone call to assist them in completing the questionnaire. The purpose of this study is to gain understanding of which patients with BE are likely to progress to malignancy, and it is equally important to determine which patients are not likely to progress. The hypothesis is that the collection of data on the natural history of BE, and risk factors for progression of BE, will provide information to develop a risk model which will also be a useful tool leading to a reduction in overall health care costs.

A Phase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized with Dilutional Hyponatremia. Symptoms And Length of stay After sodium Correction in Inpatient Adults: Tolvaptan versus Fluid Restriction. (SALACIA)

Robert O'Shea, MD

For patients admitted to the hospital who have dilutional hyponatremia (low amount of sodium or salt in the blood). The purpose of this study is to find out the potential benefits of tolvaptan in relation to the symptoms and length of hospital stays of people with dilutional hyponatremia. Although Tolvaptan is approved for use by the FDA in adults with certain types of hyponatremia, it is not approved for either the relief of symptoms associated with hyponatremia or shortening the length of time in the hospital. Patients will be randomly assigned to take either Tolvaptan or placebo for up to 7 days or until discharge from the hospital, whichever occurs first. Patient participation will last about 15 days including a follow-up phone call.

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type I with Lucassin® (Terlipressin). (REVERSE TRIAL)

David Barnes, MD

For patients admitted to the hospital who have Hepatorenal Syndrome (HRS) type 1 due to severe liver disease. The purpose of this study is to test an investigational drug called Terlipressin to see whether intravenous Terlipressin is safe and effective to treat (improve or reverse) HRS type 1 when compared to placebo. Patients will be randomly divided into two study groups (Terlipressin or placebo) and will receive the study drug or placebo into their IV every 6 hours for up to 16 days, depending on kidney function test results. Patients will be monitored closely while in the hospital and will have follow-up phone calls for up to 3 months after the end of the study treatment.

An Observational Prospective REGISTRY to Identify Demographic and Clinical Characteristics of Patients Hospitalized with Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization

Robert O'Shea, MD

The purpose of this registry is to compare the effectiveness of different treatments, including no treatment at all, for hyponatremia (low levels of sodium in the blood). Each patient will already be admitted to the hospital and their treatment will be determined by their caregiver prior to enrollment. This registry will collect data from medical charts, including age, gender, race, medical history and discharge information.

Tissue Banking of Duodenal Fluid and Serum Samples from Patients with Pancreatic Diseases

Tyler Stevens, MD

For patients who are scheduled to have an endoscopy procedure to evaluate for possible chronic pancreatitis, pancreatic cancer, or are at a high risk of developing pancreatic cancer due to a strong family history. For a comparison group, we will also recruit patients without pancreatic diseases, including those undergoing endoscopy for other purposes, or patients with viral hepatitis undergoing a liver biopsy. Fluid may be collected at the time of endoscopy during a pancreatic function test or during endoscopic ultrasound. The fluid is analyzed to see how well the pancreas is working (to diagnose chronic pancreatitis) or for the presence of cancer cells (to diagnose cancer). We will ask questions regarding medical history and risk factors for pancreatic diseases (including smoking and alcohol use) and will obtain a small sample of blood and breath for analysis. We want to understand more about certain proteins, environmental factors and other causes that are involved in chronic pancreatitis and pancreatic cancer. To achieve our goals, we will store samples of blood, breath and intestinal fluid for future research purposes.

Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFN alpha-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFN alpha and ribavirin therapy. (ATTAIN)

Nizar Zein, MD

For patients who have been diagnosed with chronic hepatitis C virus (HCV) infection and had a response to treatment with Peginterferon alfa-2a (PEG) and ribavirin (RBV) which did not cure you from hepatitis C. The purpose of this study is to find out if an experimental drug called TMC435 combined with PEG and RBV works as well or better than telaprevir with PEG and RBV to treat patients with genotype 1 HCV who were non-responders to previous PEG plus RBV therapy. Participation in this study may last about 1½ years which includes screening, a treatment period of 48 weeks and a follow-up period. The follow-up period ends 72 weeks after starting treatment.

A 2-Part, Open-Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected with Genotype 1 Hepatitis C Virus Following Liver Transplantation

Nizar Zein, MD

For patients who have had a liver transplant within 6 months to 10 years ago, who now have genotype 1 chronic hepatitis C (HCV). The purpose of this study is to learn more about the safety and effects of the combination of telaprevir, peginterferon alfa-2a (PEG) and ribavirin (RBV)in patients with HCV who have had a liver transplant. Patients will receive treatment with PEG and RBV for up to 48 weeks, and will also receive telaprevir for up to 12 weeks. None of these drugs are approved by the FDA for use in patients who have had a liver transplant. Participation could last up to 101 weeks (screening, a treatment period lasting up to 48 weeks, and a follow-up period that will last up to 48 weeks), depending on your body’s response to the study drugs.

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

Chung-Jyi Tsai, MD

For patients diagnosed with Celiac Disease who have been following a gluten free diet for at least 1 year and are actively experiencing symptoms of Celiac Disease. The purpose of this study is to look at the effectiveness and safety of three different doses of Larazotide Acetate. Patients will continue to follow their current diet and will receive study medication or placebo for up to 147 days. There will be 7 visits for tests and procedures and 1 follow-up telephone visit. Patients will be given a small hand-held electronic device to record daily and weekly diary information.

The Cleveland Clinic Foundation Inflammatory Bowel Disease DNA Bank

Jean-Paul Achkar, MD

This study is designed to recruit patients who have been diagnosed with IBD (Crohn's disease and/or Ulcerative Colitis) and their unaffected spouse/significant other/or family member (who is not genetically related). The purpose of the study is to identify the genes that cause Ulcerative Colitis and Crohn's Disease. The study consists of one study visit to include a consent form signed by both the affected and unaffected participants, along with information regarding family background and smoking history, and a donated blood sample. The affected patient will also be asked questions about their disease history, including but not limited to diagnosis, medications, surgeries and complications. The DNA, serum, plasma and accompanying information that is collected is strictly confidential and will be used in attempts to advance the understanding of genetics and IBD.

Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients

Chung-Jyi Tsai, MD

Two types of patients with celiac disease will be enrolled in this study: newly diagnosed, and those who have been diagnosed with celiac disease who have been on a gluten-free diet for at least 12 months. Patients will complete 5 surveys by telephone and internet to answer questions about your symptoms and how the gluten-free diet affects your life.

Established Celiac Disease Patients will be assigned to 1 of 4 study groups. There is a chance that you will eat a small amount of gluten over an 8 week period. Participation will last about 12 weeks, including 5 visits and 1 telephone call. The purpose is to: 1) find out how small amounts of gluten eaten daily can affect common celiac disease symptoms; 2) find out the impact of living with celiac disease and sticking to a gluten-free diet on a celiac patient’s life; 3) test whether the PRO survey is a good tool to measure symptoms that people with celiac disease commonly experience; and 4) see if treated gluten that has been broken down can cause symptoms.

Newly Diagnosed Celiac Disease patient participation will last about 16 weeks including 5 visits and 2 telephone visits. The purpose is to: 1) find out how starting a gluten-free diet in newly diagnosed patients affects symptoms and how it impacts patients’ lives; and 2) test the PRO survey and see if is a good tool to measure symptoms that people with celiac disease commonly experience.

Enhancing DCD Utilization with Thrombolytic Therapy

Bijan Eghtesad, MD

For patients who have already consented to receive a liver for transplant from a person who donated this liver after his or her heart stopped (DCD liver) . The purpose of this study is to determine if post-transplant complications due to narrowing in the biliary system (a system that collects bile from your liver tissue and excretes it into your intestines), or a blood clot formation in the liver vessels, can be prevented or reduced by treating the donated liver with a clot dissolving medication called Activase (also known as Alteplase or rTPA). Patients will be randomly assigned to one of two groups: Group 1 will receive a DCD liver followed by standard post-transplant medications and medical care; Group 2 will receive a DCD liver which will be treated with clot dissolving rTPA medication before implanting. The liver will then be implanted into the recipient who will be followed by standard post-transplant medications and medical care. Patient participation will last about 12 months , we will collect the usual labs at your regular post transplant visits month 1,3,6,9, and 12, an additional test called an MRCP, which is an MRI, will be covered by the study and done at month 3 and 6.

A Phase II Open-label Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBLHCV1) Combined With an HCV Protease Inhibitor in Hepatitis C Infected Patients Undergoing Liver Transplantation

Bijan Eghtesad, MD

For patients scheduled to undergo a liver transplant for chronic hepatitis C virus (HCV) infection. The purpose of this study is to find out if treatment with the antibody MBL-HCV1 in combination with the protease inhibitor telaprevir can prevent HCV infection of your new liver. Patient participation will last up to 98 days and may last up to 140 days depending on test results.