Actively Recruiting
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
Eligibility Criteria
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
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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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
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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