GI Neuromuscular Pathology Prospective Registry

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT02165059
Status
Recruiting
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Conditions

  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
6 Months - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Surgical Full Thickness Biopsy — PROCEDURE
    Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.

Study Details

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).

Key Dates

First listed
Jun 17, 2014
Start date
Dec 1, 2013
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes [ Time Frame: from implantation to 6 months after ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University HosptialIndianapolisIndiana46202
Maureen Schilling
[email protected]
3172782064
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)
John M Wo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Hosptial· Indianapolis, IN

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