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Terminated Phase 4 Interventional Results available

Enterra Therapy Gastric Stimulation System

ClinicalTrials.gov ID: NCT00556166

Public ClinicalTrials.gov record NCT00556166. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00556166
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Columbia University
Other
Enrollment
4 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2004
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008
Last update posted
Aug 1, 2016

2004 – 2008

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Columbia University College of Physicians and Surgeons New York New York 10032

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00556166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 1, 2016 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00556166 live on ClinicalTrials.gov.

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