Gastric Pacemaker Implantation for Gastroparesis (HUD)
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ClinicalTrials.gov Identifier: NCT00568373 |
Recruitment Status :
Withdrawn
(this is not a clinical trial and does not require registration)
First Posted : December 6, 2007
Last Update Posted : March 5, 2021
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Sponsor:
Indiana University
Information provided by (Responsible Party):
Indiana University
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Brief Summary:
Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroparesis | Device: Enterra Gastric Pacemaker | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All patients who have severe symptoms and have been identified by the PI and Sub I to qualify for the treatment will be under one single group |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology |
Estimated Study Start Date : | June 2007 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Nausea and Vomiting
Arm | Intervention/treatment |
---|---|
Experimental: Treatement
All subjects that meet the requirement for gastric stimulator placement
|
Device: Enterra Gastric Pacemaker
Gastric Pacemaker |
Information from the National Library of Medicine

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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.
No Contacts or Locations Provided
Responsible Party: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00568373 |
Other Study ID Numbers: |
0705-32 |
First Posted: | December 6, 2007 Key Record Dates |
Last Update Posted: | March 5, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Indiana University:
Gastroparesis Gastric electrical stimulator |
Additional relevant MeSH terms:
Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |