Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Male or female, aged 18-75
- 2. 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
- 3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
- 4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
- 5. 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
- 6. Stated willingness to comply with all study procedures and availability for the duration of the study
- 7. 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
- 8. Be able to speak and read the English language.
- 1. Active use of narcotic pain medication
- 2. 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)
- 3. Etiology of gastroparesis is post-surgical
- 4. Pregnancy or lactation
- 5. History of egg allergy
- 6. Prior surgical intervention of the stomach or gastric pylorus
- 7. Current parenteral nutrition
- 8. Uncontrolled coagulopathy (platelet count \<50,000 and INR\>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)
Ages Eligible for Study
18 Years to 75 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No