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Gastric Pacemaker Implantation for Gastroparesis (HUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00568373
Recruitment Status : Unknown
Verified March 2018 by Joel Wittles, Indiana University.
Recruitment status was:  Recruiting
First Posted : December 6, 2007
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Wittles, 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)
Estimated Enrollment : 200 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
Actual Study Start Date : June 2007
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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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Primary Outcome Measures :
  1. Decreased nausea and vomiting. [ Time Frame: 3 months ]

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568373


Contacts
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Contact: Anita Gupta, MBBS,,MPH 317-948-9227 anigupta@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-948-9227    anigupta@iu.edu   
Principal Investigator: Joel Wittles, MD         
Sub-Investigator: John M Wo, MD         
Sub-Investigator: Thomas V Nowak, MD         
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-948-9227    anigupta@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Joel Wittles, MD Indiana University
Study Chair: John M Wo, MD Indiana University
More Information
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Responsible Party: Joel Wittles, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00568373    
Other Study ID Numbers: 0705-32
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joel Wittles, 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