TerminatedNot Applicable

Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis

Stopped: Excessive stent migration.

United States8 participantsStarted 2019-05-15

Plain-language summary

This is a prospective sham study to investigate the role of transpyloric stenting with lumen apposing metal stent (LAMS) as a predictor for clinical response to gastric per-oral endoscopic pyloromyotomy (GPOEM) for refractory gastroparesis. The study hypothesizes that clinical improvement with transpyloric stenting in patients with refractory gastroparesis is a predictor of subsequent clinical success of GPOEM.

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: * Adult patients greater than 18 years of age with gastroparesis refractory to standard medical therapy (lifestyle and diet modifications, prokinetics) or contraindication to standard therapies (e.g. allergies to prokinetic agents) * Patients with diabetic, idiopathic or post-surgical gastroparesis * Patients with confirmed diagnosis of gastroparesis via gastric emptying study (abnormal gastric emptying will be defined as ≥10 % residual activity at 4 h on a standardized nuclear medicine TC-99 m sulfur colloid solid-phase gastric emptying study) Exclusion Criteria: * Patients with prior history of gastroenteric anastomosis or any GI surgeries with pyloric involvement * Patients with gastroesophageal malignancy * Patients who are unable to tolerate upper endoscopy secondary to cardiopulmonary instability or other contraindications to endoscopy * Patients with cirrhosis * Patients who are pregnant or breastfeeding * Patients with uncorrectable coagulopathy defined by INR \>1.5 or platelets \<50

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

Clinical response will be assessed by the gastroparesis cardinal symptom index (GCSI) scores

Timeframe: 1-2 years

Trial details

NCT IDNCT04287647

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-27

View on ClinicalTrials.gov More Gastroparesis trials