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Gastric Pacemaker Implantation for Gastroparesis (HUD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Indiana University
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine ) Identifier:
First received: December 4, 2007
Last updated: July 20, 2015
Last verified: July 2015
Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Condition Intervention
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:

Further study details as provided by Indiana University:

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

Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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.

Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00568373

Contact: Anita Gupta 317-948-9227

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

Responsible Party: Indiana University School of Medicine Identifier: NCT00568373     History of Changes
Other Study ID Numbers: 0705-32
Study First Received: December 4, 2007
Last Updated: July 20, 2015

Keywords provided by Indiana University:
Gastric electrical stimulator

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 23, 2017