Registry for understanding gastroparesis and related motility disorders
Official title: Indiana University GI Neuromuscular Pathology Prospective Registry
Run by Indiana University · NCT02165059 · Data updated 2026-11-12
This study is trying to understand the causes of gastroparesis and related digestive issues by collecting samples and information from patients having surgery for these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Months to 90 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | December 1, 2013 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT02165059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with gastroparesis who are scheduled for surgical biopsy and those undergoing specific digestive surgeries without gastroparesis.
✕Probably not a fit
Patients with significant comorbidities, contraindications for biopsy, or prior diagnoses of gastroparesis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects biopsy samples from patients diagnosed with gastroparesis who are undergoing gastric electrical stimulation implantation surgery. It also includes a control group of patients without gastroparesis undergoing various digestive surgeries. The study aims to investigate the underlying causes of motility disorders, assess symptom severity through questionnaires, and follow patients over 24 months to evaluate outcomes. The collected data will help direct future investigations and improve prognosis for patients with these conditions.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of gastroparesis, improving treatment options for patients.
How similar studies have gone: While similar studies have explored motility disorders, this specific registry approach focusing on biopsy samples is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria Study Group: Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder. Inclusion Criteria Control Group: 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 Exclusion Criteria Study Group: 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 Exclusion Criteria Control Group: Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor
Where it's running
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Indiana University Hosptial
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: John M Wo, MD — Indiana University
- Study coordinator: Maureen M Schilling, MD
- Email: maschi@iu.edu
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.