Clinical trial NCT00432835: Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Official title: Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroparesis
Keywords: Nausea
Vomiting
Delayed gastric emptying
Diabetes Mellitus
Post-Surgical
Idiopathic
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2007-02-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Symptom of Vomiting Associated With Gastroparesis
timeFrame: Study Day 0 (Baseline), Day 3, Day 7
measure: Symptom of Nausea Associated With Gastroparesis
timeFrame: Study Day 0 (Baseline), Day 3, Day 7
measure: Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
timeFrame: Study Day 0 (Baseline), Day 4, Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Thomas L Abell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.gie.2011.05.022.