WithdrawnNot Applicable

Use of EndoFLIP and Manometry Prior to G-POEM

Stopped: Unable to complete study procedures due to staffing issues.

United States0Started 2021-09-15

Plain-language summary

The purpose of this study is to assess physiologic response of therapy in patients with refractory gastroparesis undergoing Gastric per-oral endoscopic myotomy (G-POEM) using endoscopic functional lumen imaging probe (EndoFLIP) and antroduodenal manometry (ADM). Refractory gastroparesis will be defined as having delayed gastric emptying at four hours (\>10% retention of stomach contents) on gastric scintigraphy and persistent symptoms despite treatment with dietary modification or prokinetic medications. We hypothesize that EndoFLIP and high resolution ADM will provide an individualized pyloric functional profile in gastroparesis patients that can more accurately predict clinical response to G-POEM.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients aged 18+ diagnosed with refractory gastroparesis as defined earlier in this document, no age limit * Patients already consented to undergo G-POEM Exclusion Criteria: * Patients who are pregnant(at Northwestern, all female patients have urine pregnancy tests on day of endoscopy), vulnerable populations such as prisoners, * Life expectancy \< 1 year based on concurrent comorbidities based on study team assessment, * Coagulopathy with INR \> 1.5 that cannot be reversed, * Thrombocytopenia with platelets \< 50,000 that cannot be corrected with blood products, * Unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope. * Patients with history of gastric surgery and * Active narcotic use at time of G-POEM evaluation within four weeks. Tobacco use is not an exclusion criterion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predictive Value of EndoFLIP

Timeframe: 24 months

Predictive Value of ADM

Timeframe: 24 months

Trial details

NCT IDNCT04844190

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Gastroparesis trials