Phase 3
N=58
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT00432835 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Symptom of Vomiting Associated With Gastroparesis — 1.82; 2.68; 0.17; 1.20 Patient Self-reported Symptom Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gastric Electrical Stimulator, Enterra, Medtronics, Inc. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Mississippi Medical Center
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom of Vomiting Associated With Gastroparesis |
1.82; 2.68; 0.17; 1.20; 0.91; 0.72 | — |
| PRIMARY Symptom of Nausea Associated With Gastroparesis |
3.27; 3.33; 1.46; 1.67; 2.26; 1.4 | — |
| PRIMARY Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis |
67.07; 66.13; 69.96; 37.41; 64.71; 16.43 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT00432835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.