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Enterra Therapy Gastric Stimulation System

This study has been terminated.
(Principal investigator left institution.)
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00556166
First received: November 8, 2007
Last updated: February 1, 2011
Last verified: February 2011
History of Changes
  Purpose

Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin.

In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven.

Physicians at Columbia University Medical Center hope to prove the helpfulness of this device.


Condition Intervention Phase
Gastroparesis
 Device: Enterra Therapy Gastric Stimulator
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enterra Therapy Gastric Stimulation System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Incidence of number of episodes of nausea and vomiting. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence in number of episodes of abdominal pain, bloating, and early satiety. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Subjects enrolled in this study have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
 Device: Enterra Therapy Gastric Stimulator

The intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2" x 2" x 1/2" and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis.

The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic(long term, lasting greater than 3 months)
  • Intractable (drug refractory, failed medical management with prokinetic and antiemetic drugs
  • Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology

Exclusion Criteria:

  • Only patients whom the physician determines are not a candidate for surgical procedures and/or anesthesia due to physical or mental conditions will be excluded. This includes pregnant women, anyone unable to tolerate general anesthesia, and uncorrectable coagulopathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556166

Locations
United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Dennis L. Fowler, M.D. Columbia University College of Physicians and Surgeons
  More Information

No publications provided

Responsible Party: Dennis Fowler, Columbia University
ClinicalTrials.gov Identifier: NCT00556166     History of Changes
Other Study ID Numbers: AAAA5072
Study First Received: November 8, 2007
Last Updated: February 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Enterra therapy

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 19, 2013