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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Recruitment Status : Withdrawn (this is not a clinical trial and does not require registration)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
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Description
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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

Detailed Description:
Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.
Study Design
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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


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatement
All subjects that meet the requirement for gastric stimulator placement
 Device: Enterra Gastric Pacemaker
Gastric Pacemaker


Outcome Measures
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Eligibility Criteria
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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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations