Gastric Pacemaker Implantation for Gastroparesis (HUD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 6, 2014
Last verified: June 2014
  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:


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: 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.

  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
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 ClinicalTrials.gov identifier: 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

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: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Gastroparesis
Gastric electrical stimulator

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

ClinicalTrials.gov processed this record on July 20, 2014