Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04287647

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

Led by Northwestern University · Updated on 2025-02-17

36

Participants Needed

1

Research Sites

368 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients greater than 18 years of age with gastroparesis refractory to standard medical therapy or contraindication to standard therapies
  • Patients with diabetic, idiopathic, or post-surgical gastroparesis
  • Patients with a confirmed diagnosis of gastroparesis by gastric emptying study showing 10% residual activity at 4 hours on a standardized nuclear medicine TC-99 m sulfur colloid solid-phase study
Not Eligible

You will not qualify if you...

  • Patients with prior history of gastroenteric anastomosis or any gastrointestinal surgeries involving the pylorus
  • Patients with gastroesophageal malignancy
  • Patients unable to tolerate upper endoscopy due to cardiopulmonary instability or other contraindications
  • Patients with cirrhosis
  • Patients who are pregnant or breastfeeding
  • Patients with uncorrectable coagulopathy defined by INR >1.5 or platelets <50

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

A

A. Aziz Aadam, MD

CONTACT

K

Kevin Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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