HUD: Gastric Pacemaker Implantation for Gastroparesis
Sponsor
Indiana University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00568373
Collaborator
(none)
0
1
222
Study Details
Study Description
Brief Summary
Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.
Study Design
Study Type:
Interventional
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 groupAll 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
Anticipated Study Start Date
:
Jun 1, 2007
Anticipated Primary Completion Date
:
Dec 1, 2025
Anticipated Study Completion Date
:
Dec 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatement All subjects that meet the requirement for gastric stimulator placement |
Device: Enterra Gastric Pacemaker
Gastric Pacemaker
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
No locations specified.Sponsors and Collaborators
- Indiana University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Indiana University
ClinicalTrials.gov Identifier:
NCT00568373
Other Study ID Numbers:
- 0705-32
First Posted:
Dec 6, 2007
Last Update Posted:
Mar 5, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Indiana University
Additional relevant MeSH terms: