GI Neuromuscular Pathology Prospective Registry
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|ClinicalTrials.gov Identifier: NCT02165059|
Recruitment Status : Recruiting
First Posted : June 17, 2014
Last Update Posted : October 13, 2017
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Indiana University GI Neuromuscular Pathology Prospective Registry|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Patients undergoing surgical full thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.
Patient undergoing esophagectomy, sleeve gastrectomy for obesity, Roux-en-Y gastric bypass, Whipple surgery, transplant surgery.
Patients who are organ donors and undergoing surgery are also part of the control group.
- Clinical data at 4 time periods for study patents will be measured [ Time Frame: 2 years ]
Follow up clinical data will be obtained before, 6 months, 1.5 years, and 2 years after the full thickness biopsy.
Follow up clinical data PAGI-SYM Overall Treatment Effect by Patient Overall Treatment Effect by Physician
- Positive Clinical Outcome to surgical implantation of GES measured by GCSI [ Time Frame: 6 months ]Responders will be defined as >50% improvement of the GCSI total score at 6 month after surgical GES
- Neuromuscular pathology results of the gastric body and proximal jejunum wil be compared between the following groups [ Time Frame: 6 months ]
Patients with gastroparesis from type 1 DM versus patients with idiopathic gastroparesis.
Patients with gastroparesis from type I DM versus gastroparesis from type 2 DM
- Correlation of Pathology Results and Questionnaire [ Time Frame: 6 months ]Neuromuscular pathology results of the gastric body and proximal jejunum will be correlated with the following: Symptom severity (GCSI total score), predominant symptom presentation, severity of delayed gastric emptying.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165059
|Contact: Anita Gupta, MBBS, MPHfirstname.lastname@example.org|
|Contact: Miranda Williams, BSemail@example.com|
|United States, Indiana|
|Indiana University Hosptial||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Anita Gupta, MBBS, MPH 317-948-9227 firstname.lastname@example.org|
|Sub-Investigator: Tom V Nowak, MD|
|Sub-Investigator: Attila Nakeeb, MD|
|Sub-Investigator: Paul Herring, PhD|
|Sub-Investigator: Muhammad T Idress|
|Sub-Investigator: Chandrashekhar A Kubal, MD|
|Sub-Investigator: Jennifer Choi, MD|
|Sub-Investigator: Andrea Shin, MD/Fellow|
|Principal Investigator:||John M Wo, MD||Indiana University|