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Gastric Pacemaker Implantation for Gastroparesis (HUD)

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ClinicalTrials.gov Identifier: NCT00568373
Recruitment Status : Recruiting
First Posted : December 6, 2007
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Wittles, Indiana University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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


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




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


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.

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

Locations
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
Principal Investigator: Joel Wittles, MD Indiana University
Study Chair: John M Wo, MD Indiana University

Responsible Party: Joel Wittles, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00568373     History of Changes
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:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms