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Gastric Pacemaker Implantation for Gastroparesis (HUD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Indiana University ( Indiana University School of Medicine ).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568373
First Posted: December 6, 2007
Last Update Posted: July 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
  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: None (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 ( Indiana University School of Medicine ):

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00568373     History of Changes
Other Study ID Numbers: 0705-32
First Submitted: December 4, 2007
First Posted: December 6, 2007
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Indiana University ( Indiana University School of Medicine ):
Gastroparesis
Gastric electrical stimulator

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