Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID: NCT00432835
Run by: University of Mississippi Medical Center
People needed: 58
Starts: 2005-08-01
Expected to finish: 2007-11-01
Last updated by the study team: 2012-12-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Mississippi Medical Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.