ACTIVE_NOT_RECRUITING

Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)

Quick Facts

Study Start:2022-02-23

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05039424

Participation Criteria

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Principal Investigator

Matthew Allemang, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Matthew Allemang

Matthew Allemang, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-23

Study Completion Date2026-07

Study Record Updates

Study Start Date2022-02-23

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Gastroparesis