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Gastric Pacemaker Implantation for Gastroparesis (HUD)
This study is currently recruiting participants.
Verified October 2011 by Indiana University

First Received on December 4, 2007.   Last Updated on October 18, 2011   History of Changes
Sponsor: Indiana University School of Medicine
Information provided by (Responsible Party): Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00568373
  Purpose

Gastric pacemakers will be surgically implanted in eligible patients.


Condition Intervention
Gastroparesis
 Device: Enterra Gastric Pacemaker

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting
U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Decreased nausea and vomiting. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gastric pacemaker.
 Device: Enterra Gastric Pacemaker
Gastric Pacemaker

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568373

Contacts
Contact: Shannon Robinson, RN 317-948-2766 mrobins6@iuhealth.org

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shannon Robinson, RN     317-948-2766     mrobins6@iuhealth.org    
Principal Investigator: Joel Wittles, MD            
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shannon Robinson, RN     317-948-2766     mrobins6@iuhealth.org    
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Joel Wittles, MD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00568373     History of Changes
Other Study ID Numbers: 0705-32
Study First Received: December 4, 2007
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 02, 2012



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