Enterra Therapy Gastric Stimulation System (Enterra)
Primary Purpose
Gastroparesis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enterra Therapy Gastric Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Enterra therapy, Gastric Simulation System
Eligibility 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.
Sites / Locations
- Columbia University College of Physicians and Surgeons
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enterra Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Episodes of Nausea and Vomiting
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
Data was not analyzed because PI left institution and terminated the study early.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00556166
Brief Title
Enterra Therapy Gastric Stimulation System
Acronym
Enterra
Official Title
Enterra Therapy Gastric Stimulation System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator left institution.
Study Start Date
October 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Enterra therapy, Gastric Simulation System
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enterra Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Enterra Therapy Gastric Stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Episodes of Nausea and Vomiting
Description
Data was not analyzed because PI left institution and terminated the study early.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Episodes of Abdominal Pain, Bloating, and Early Satiety
Description
Data was not analyzed because PI left institution and terminated the study early.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis L. Fowler, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data available to share as the PI left the institution before the study could finish.
Learn more about this trial
Enterra Therapy Gastric Stimulation System
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