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Transpyloric Stenting for Gastroparesis

N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights

Study Summary

This trial will test whether a metal stent placed across the pylorus predicts success of a later endoscopic pyloromyotomy for patients with refractory gastroparesis.

Who is the study for?
This trial is for adults over 18 with gastroparesis that hasn't improved with standard treatments or those who can't take them due to allergies. It's open to patients with diabetic, idiopathic, or post-surgical forms of the condition confirmed by a gastric emptying study. People can't join if they've had certain GI surgeries, cancer in the stomach area, are unstable for endoscopy procedures, have liver cirrhosis, are pregnant/breastfeeding, or have significant blood clotting issues.Check my eligibility
What is being tested?
The study is testing whether placing a transpyloric stent (a type of tube) across the pylorus (the stomach's exit) predicts success for a later procedure called G-POEM in treating severe gastroparesis. Participants will be randomly assigned to receive either the actual stenting procedure or a sham (fake) procedure as part of this forward-looking research.See study design
What are the potential side effects?
Potential side effects from transpyloric stenting may include discomfort at the stent site, risk of infection, bleeding during placement and possible migration or blockage caused by the stent. The severity and occurrence can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have gastroparesis due to diabetes, surgery, or an unknown cause.
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I have been diagnosed with gastroparesis through a gastric emptying study.
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I am over 18 with gastroparesis not improved by standard treatments or cannot use them due to allergies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical response will be assessed by the gastroparesis cardinal symptom index (GCSI) scores
Secondary outcome measures
Adverse events
Age
BMI
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Transpyloric stentActive Control1 Intervention
In this group, patient's will be randomized to receive a transpyloric stent for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.
Group II: ShamPlacebo Group1 Intervention
In this group, patient's will be randomized to sham for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,195 Total Patients Enrolled
1 Trials studying Gastroparesis
1 Patients Enrolled for Gastroparesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to join this experiment in its current phase?

"Affirmative. Clinicaltrials.gov displays that this research study, which was posted on May 15th 2019, is actively trying to enroll individuals. 36 volunteers must be enrolled from a single medical facility."

Answered by AI

How many participants can partake in this experiment at its peak?

"Correct. Clinicaltrials.gov attests that this clinical trial is currently recruiting and was first posted on May 15th 2019 with the last update occurring September 30th 2021. 36 participants are needed to take part in the experiment held at one medical site."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis
A. Aziz Aadam 2019. "Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04287647.
All > Diabetic Gastroparesis > Gastroparesis
~1 spots leftby Jun 2024
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