Enterra Therapy Gastric Stimulation System (Enterra)

This study has been terminated.
(Principal investigator left institution.)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00556166
First received: November 8, 2007
Last updated: June 22, 2016
Last verified: June 2016
  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:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of Episodes of Nausea and Vomiting [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Data was not analyzed because PI left institution and terminated the study early.


Secondary Outcome Measures:
  • Number of Episodes of Abdominal Pain, Bloating, and Early Satiety [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Data was not analyzed because PI left institution and terminated the study early.


Enrollment: 4
Study Start Date: October 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enterra Therapy
The Enterra Therapy Gastric Stimulator will be used on subjects who 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.


Detailed Description:

Gastroparesis is a debilitating disease in which patients suffer from a number of upper gastrointestinal (GI) symptoms including nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and burning, and cardiac pain and burning. Severe symptoms, particularly vomiting and nausea, can significantly impair a patients daily activities and quality of life.

Current medical practice for the treatment and/or management of gastroparesis consists of dietary modifications, drug therapies, enteral feeding, parenteral feeding and surgery. These treatments are successful for some patients, but have significant drawbacks. Patients may initially be treated with various dietary modifications including frequent low fat meals. However, if dietary modifications alone are unsuccessful, antiemetic and prokinetic drugs, or combinations thereof, are generally tried. If symptoms cannot be controlled with medication, supplemental nutrition via enteral or parenteral feeding may be required to maintain hydration and nutritional status. Prokinetic drugs are intended to promote gastric motility, i.e., to return abnormally slow gastric emptying states to normal. Antiemetic drugs are intended to alleviate symptoms of nausea and vomiting, but have no effect on motility. None of the prokinetic drugs are labeled for improved gastric emptying in gastroparesis. Metoclopramide is the only antiemetic or prokinetic drug indicated for use in the treatment of symptoms of diabetic gastroparesis.

Surgical procedures are occasionally employed to manage symptoms of gastroparesis while maintaining the ability for enteral feeding. Surgical procedures, including gastrectomy, pyloroplasty, and gastrojejunostomy, have had limited success in managing symptoms of gastroparesis. When drug therapies or surgery are ineffective, supplemental enteral feeding via gastric or jejunal feeding tubes or total parenteral nutrition (TPN) may be required to meet the patient's nutritional needs.

For those patients who cannot be adequately treated or managed by current medical practice, the GES has no satisfactory alternative. It is this group of patients for which the GES System is indicated.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
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: 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
  More Information

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00556166     History of Changes
Other Study ID Numbers: AAAA5072 
Study First Received: November 8, 2007
Results First Received: April 18, 2016
Last Updated: June 22, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No data available to share as the PI left the institution before the study could finish.

Keywords provided by Columbia University:
Enterra therapy
Gastric Simulation System

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

ClinicalTrials.gov processed this record on August 30, 2016