IRB Study Number 20-160
Status Recruiting
Locations Cleveland Clinic Main Campus, South Pointe Hospital
Institute Digestive Disease & Surgery Institute
Description
The purpose of this study is to determine if a procedure called, per-oral pyloromyotomy (POP), is effective for treating patients with gastroparesis. The safety and effectiveness of this procedure has not been established.
POP is a nonsurgical procedure in which the doctor inserts an endoscope (a long, thin, flexible instrument) into the patient’s mouth and advances it to the stomach. The doctor then cuts the pylorus, the valve that empties the stomach, which allows food to move from the stomach to the small intestine more easily. After the procedure, you will be asked how you feel by talking to the research team or by filling out questionnaires.
Your participation in the research will last about one year
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18-75
- Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms
- Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
- Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary
- Be able to speak and read the English language.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
- Active use of narcotic pain medication
- Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or < 3 bowel movements per week)
- Etiology of gastroparesis is post-surgical
- Pregnancy or lactation
- History of egg allergy
- Prior surgical intervention of the stomach or gastric pylorus
- Current parenteral nutrition
- Uncontrolled coagulopathy (platelet count <50,000 and INR>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)
