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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 July 2015 by Indiana University ( Indiana University School of Medicine ).
Recruitment status was:  Recruiting
First Posted : December 6, 2007
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Condition or disease Intervention/treatment
Gastroparesis Device: Enterra Gastric Pacemaker

Detailed Description:
Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
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
Study Start Date : June 2007
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Gastric pacemaker.
Device: Enterra Gastric Pacemaker
Gastric Pacemaker


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

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 317-948-9227 anigupta@iupui.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-948-9227    anigupta@iupui.edu   
Principal Investigator: Joel Wittles, MD         
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta    317-948-9227    anigupta@iupui.edu   
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Joel Wittles, MD Indiana University
More Information

Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00568373     History of Changes
Other Study ID Numbers: 0705-32
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Indiana University ( Indiana University School of Medicine ):
Gastroparesis
Gastric electrical stimulator

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms