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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. 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
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.

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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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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 identifier (NCT number): NCT00568373

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Contact: Anita Gupta, MBBS,,MPH 317-948-9227

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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-948-9227   
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   
Sponsors and Collaborators
Indiana University
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Principal Investigator: Joel Wittles, MD Indiana University
Study Chair: John M Wo, MD Indiana University
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Responsible Party: Joel Wittles, MD, Indiana University 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:
Gastric electrical stimulator
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations