Gut tissue samples to study the causes of gastroparesis
Collects gut tissue samples from people with gastroparesis to study its underlying causes.
Key facts
- Who runs it
- Indiana University
- Where
- Indianapolis, United StatesSee the site
- Trial code
- Registry title
- GI Neuromuscular Pathology Prospective Registry
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 1 Dec 2013
- Expected to end
- Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Surgical Full Thickness Biopsy
- Record updated
- 16 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people having surgery to take a full-thickness biopsy (tissue sample) of the stomach or upper small bowel to check for a gut nerve-muscle disorder such as gastroparesis. It also takes a control group of people having certain other stomach or bowel surgeries, transplant surgery, or organ donation surgery.
- Age
- 6 Months to 90 Years
- Sex
- All
- Disease stage
- Study group: people being checked for a gut nerve-muscle disorder (a problem with how the gut moves food). Control group: people without such a disorder having esophagectomy, sleeve gastrectomy for obesity, Roux-en Y gastric bypass, Whipple surgery, transplant surgery, or organ donor surgery.
Main reasons for not taking part
- Study group: any reason the biopsy surgery cannot be done, or serious heart, kidney, lung or liver disease
- Study group: serious blood clotting problems, being bed-ridden or living in a nursing home
- Study group: being pregnant or a prisoner
- Control group: an earlier diagnosis of gastroparesis or chronic intestinal pseudo-obstruction
- Not able to give your own consent (except organ donors in the control group)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder
- Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery
- Patients who are organ donors and undergoing surgery
Who cannot take part
- Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor
- Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease
- Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners
Where in United States
- Indiana University HosptialIndianapolis, United StatesContact: John WoTaking people
About the trial
What the trial wants to find out
In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).
The 2 groups in the trial
- GI Neuromuscal Disorder Cohort
Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder
Treatment: Surgical Full Thickness Biopsy
- GI Surgery Patients without neuromuscal disorders (control) cohort
Patients undergoing esophagectomy, sleeve gastrectomy for obesity, Roux-en-Y gastric bypass, whipple surgery, transplant surgery, or organ donors.
Treatment: Surgical Full Thickness Biopsy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Indiana University GI Neuromuscular Pathology Prospective Registry
- Plain-language title
- Gut tissue samples to study the causes of gastroparesisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 16 June 2026