RecruitingNot Applicable

GI Neuromuscular Pathology Prospective Registry

United States300 participantsStarted 2013-12

Plain-language summary

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).

Who can participate

Age range6 Months – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes

Timeframe: from implantation to 6 months after

Trial details

NCT IDNCT02165059

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

Contact for this trial

Maureen Schilling

maschi@iu.edu

View on ClinicalTrials.gov More Gastroparesis trials