Gastric Pacemaker Implantation for Gastroparesis

Overview

Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Full Title of Study: “Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

Detailed Description

Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Interventions

  • Device: Enterra Gastric Pacemaker
    • Gastric Pacemaker

Arms, Groups and Cohorts

  • Experimental: Treatement
    • All subjects that meet the requirement for gastric stimulator placement

Participating in This Clinical Trial

Inclusion Criteria

  • Used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.