Recruiting

Gastric Electrical Stimulation

Sponsor:

Indiana University

Code:

NCT02165059

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

Surgical Full Thickness Biopsy

Study Details

Brief 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).

Conditions

Gastroparesis

Study ID

NCT02165059

Start date

Dec 1, 2013

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Interventions

Surgical Full Thickness Biopsy

Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Maureen M Schilling, MD

maschi@iu.edu

John Wo

jmwo@iu.edu

Locations

Indiana University Hosptial

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

John Wo

jwo@iu.edu

Maureen Schilling

3172782064maschi@iu.edu

Principal Investigator:

John M Wo, MD

More Information

Sponsor

Indiana University

Last update posted

Jun 16, 2026

Last verified

Aug, 2025

Keywords

  • Nausea
  • Vomiting
  • Functional dyspepsia
  • Bloating
  • Regurgitation
  • Retching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-16.