Enterra Therapy Gastric Stimulation System

NCT00556166 | Terminated Phase 4 Results

• 1 other identifier: AAAA5072
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis

Keywords

Enterra therapy; Gastric Simulation System

Outcome Measures

Primary Outcomes (1)

• Number of Episodes of Nausea and Vomiting

  Data was not analyzed because PI left institution and terminated the study early.

  1 year

Secondary Outcomes (1)

• Number of Episodes of Abdominal Pain, Bloating, and Early Satiety

  1 year

Study Arms (1)

Enterra Therapy

EXPERIMENTAL

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

Interventions

Enterra Therapy Gastric Stimulator DEVICE

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.

Enterra Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dennis Fowler
• Organization: Columbia University

dlf91@columbia.edu

212-305-9914

Study Officials

• Dennis L. Fowler, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: October 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 2, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)