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Active Not Recruiting NCT05039424

Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

Conditions: Gastroparesis

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Matthew Allemang

Location: Cleveland Clinic Foundation Cleveland Ohio

Summary

A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.

Eligibility Criteria

Inclusion 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. Exclusion Criteria: 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 \1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05039424). StuddyBuddy aggregates publicly available trial information.