CompletedPhase 3

Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

United States58 participantsStarted 2005-08

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symptom of Vomiting Associated With Gastroparesis

Timeframe: Study Day 0 (Baseline), Day 3, Day 7

Symptom of Nausea Associated With Gastroparesis

Timeframe: Study Day 0 (Baseline), Day 3, Day 7

Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis

Timeframe: Study Day 0 (Baseline), Day 4, Day 8

Trial details

NCT IDNCT00432835

SponsorUniversity of Mississippi Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-10

Results submitted2012-04-11

View on ClinicalTrials.gov More Gastroparesis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Symptom of Vomiting Associated With Gastroparesis

Timeframe: Study Day 0 (Baseline), Day 3, Day 7

Symptom of Nausea Associated With Gastroparesis

Timeframe: Study Day 0 (Baseline), Day 3, Day 7

Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis

Timeframe: Study Day 0 (Baseline), Day 4, Day 8