Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

  • STATUS
    Recruiting
  • End date
    Jul 22, 2026
  • participants needed
    100
  • sponsor
    The Cleveland Clinic
Updated on 22 December 2021
anesthesia
endoscopy
upper endoscopy
gastric emptying study
pyloromyotomy

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.

Description

A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.

Details
Condition Gastroparesis
Treatment Endoscopic per-oral pyloromyotomy (POP), Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption
Clinical Study IdentifierNCT05039424
SponsorThe Cleveland Clinic
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged 18-65
Diagnosis of medically refractive gastroparesis by 4-hour non-extrapolated solid phase gastric emptying study within 90 days
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
Ability to speak and read in the English Language

Exclusion Criteria

Active use of narcotic pain medication
Presence of concomitant gastrointestinal transit disorder such as small bowel or colonic dysmotility
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 other anticoagulant medications (with the exception of antiplatelet therapy)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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