Gastric Pacemaker Implantation for Gastroparesis (HUD)

March 3, 2021 updated by: Indiana University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatement
All subjects that meet the requirement for gastric stimulator placement
Device: Enterra Gastric Pacemaker
Gastric Pacemaker

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2007

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0705-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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