Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Gastroparesis Clinical Trial

Official title:

Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432835
• Other study ID #: 2004-0185
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2007
• Last updated: November 1, 2012
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: November 2012
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom of Vomiting Associated With Gastroparesis	Likert Scale 0-4 (low-high) using a patient reported outcomes tool	Study Day 0 (Baseline), Day 3, Day 7	No
Primary	Symptom of Nausea Associated With Gastroparesis	Likert Scale 0-4 (low-high) using a patient reported outcomes tool	Study Day 0 (Baseline), Day 3, Day 7	No
Primary	Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis	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.	Study Day 0 (Baseline), Day 4, Day 8	No

External Links

•   Pub Med abstract of study as reported in "Gastrointestinal Endoscopy"