Gastric Pacemaker Implantation for Gastroparesis - Full Text View

Gastric Pacemaker Implantation for Gastroparesis (HUD)

This study is ongoing, but not recruiting participants.

First Received: December 4, 2007 Last Updated: June 15, 2009 History of Changes

Sponsor:	Indiana University School of Medicine
Information provided by:	Indiana University
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:	Treatment, Open Label, Uncontrolled, Single Group Assignment
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

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:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gastric pacemaker.	Device: Enterra Gastric Pacemaker Gastric Pacemaker

Eligibility

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

Locations

United States, Indiana
Indiana University
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 ( Joel Witles MD )
Study ID Numbers:	0705-32
Study First Received:	December 4, 2007
Last Updated:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00568373 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases

Gastrointestinal Diseases
Neurologic Manifestations
Gastroparesis

ClinicalTrials.gov processed this record on March 10, 2010