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Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Abell, MD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00432835
First received: February 7, 2007
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.


Condition Intervention Phase
Gastroparesis
Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Symptom of Vomiting Associated With Gastroparesis [ Time Frame: Study Day 0 (Baseline), Day 3, Day 7 ] [ Designated as safety issue: No ]
    Likert Scale 0-4 (low-high) using a patient reported outcomes tool

  • Symptom of Nausea Associated With Gastroparesis [ Time Frame: Study Day 0 (Baseline), Day 3, Day 7 ] [ Designated as safety issue: No ]
    Likert Scale 0-4 (low-high) using a patient reported outcomes tool

  • Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis [ Time Frame: Study Day 0 (Baseline), Day 4, Day 8 ] [ Designated as safety issue: No ]
    Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.


Enrollment: 58
Study Start Date: August 2005
Study Completion Date: November 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gastric Stimulation Days1-4/Sham5-8
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
Other Name: No other name currently exists.
Active Comparator: Sham1-4/Gastric Stimulation Days5-8
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
Other Name: No other name currently exists.

Detailed Description:

Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped.

Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation, we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sex: Male of Female
  • Age Range: 18 to 70 inclusive
  • Patients with GP of diabetic, surgically related or idiopathic etiology.
  • Symptoms of GP for >/= 1 year.
  • Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)
  • Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values.
  • The patient is willing and able to provide informed consent.
  • The patient is willing and able to return for required follow-up visits.

Exclusion Criteria:

  • Patients < 18 or >70 years in age.
  • Patients with an active infection of any kind.
  • Patients who the investigator determines are not candidates for endoscopic procedures.
  • Women who are pregnant
  • Inability or unwillingness to provide informed consent
  • Unwilling or unable to return for required follow-up visits and examinations.
  • Patients who are currently enrolled in another investigation of a medical device or drug.
  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: NCT00432835

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Medtronic
Investigators
Principal Investigator: Thomas L Abell, MD University of Mississippi Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Abell, MD, Principal Investigator, Professor of Medicine, Director, Division of Digestive Diseases, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00432835     History of Changes
Other Study ID Numbers: 2004-0185
Study First Received: February 7, 2007
Results First Received: April 11, 2012
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Nausea
Vomiting
Delayed gastric emptying
Diabetes Mellitus
Post-Surgical
Idiopathic

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

ClinicalTrials.gov processed this record on November 25, 2014