Text Size

Gastric Pacemaker Implantation for Gastroparesis (HUD)

This study is currently recruiting participants.
Verified January 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00568373
First received: December 4, 2007
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

Gastric pacemakers and/or temporary gastric stimulators will be 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:

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: 40
Study Start Date: June 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gastric pacemaker.
 Device: Enterra Gastric Pacemaker
Gastric Pacemaker

Detailed Description:

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

  Eligibility

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            
Riley Hospital for Children Active, not recruiting
Indianapolis, Indiana, United States, 46202
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: January 9, 2013
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 May 16, 2013