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Gastric Pacemaker Implantation for Gastroparesis (HUD)

Primary Purpose

Gastroparesis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enterra Gastric Pacemaker
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Gastric electrical stimulator

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatement

    Arm Description

    All subjects that meet the requirement for gastric stimulator placement

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2007
    Last Updated
    March 3, 2021
    Sponsor
    Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00568373
    Brief Title
    Gastric Pacemaker Implantation for Gastroparesis
    Acronym
    HUD
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    this is not a clinical trial and does not require registration
    Study Start Date
    June 2007 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Indiana University

    4. Oversight

    5. Study Description

    Brief Summary
    Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.
    Detailed Description
    Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroparesis
    Keywords
    Gastroparesis, Gastric electrical stimulator

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatement
    Arm Type
    Experimental
    Arm Description
    All subjects that meet the requirement for gastric stimulator placement
    Intervention Type
    Device
    Intervention Name(s)
    Enterra Gastric Pacemaker
    Intervention Description
    Gastric Pacemaker

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Gastric Pacemaker Implantation for Gastroparesis

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