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
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