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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

February 7, 2007
November 1, 2012
August 2005
October 2006   (final data collection date for primary outcome measure)
  • 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.
The primary outcome measure of this trial is to demonstrate that temporary GES with the device ON will decrease GI symptoms by fifty percent.
Complete list of historical versions of study NCT00432835 on ClinicalTrials.gov Archive Site
Not Provided
The secondary outcome measures of the trial are to demonstrate changes in stomach emptying rate assessed via gastric emptying and improvement in quality of life (QOL) assessed via patient self rating.
Not Provided
Not Provided
 
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroparesis
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: 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
    Intervention: Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
  • 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.
    Intervention: Device: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
Abell TL, Johnson WD, Kedar A, Runnels JM, Thompson J, Weeks ES, Minocha A, Griswold ME. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011 Sep;74(3):496-503.e3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
November 2007
October 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432835
2004-0185
Yes
Thomas Abell, MD, University of Mississippi Medical Center
University of Mississippi Medical Center
Medtronic
Principal Investigator: Thomas L Abell, MD University of Mississippi Medical Center
University of Mississippi Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP