Enterra Programming for Gastroparesis
(RESTING Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you are on stable medical therapy for gastroparesis symptoms. This suggests you may need to continue your current medications.
What data supports the effectiveness of the treatment Enterra Therapy System for gastroparesis?
Is Enterra Therapy safe for humans?
Is the Enterra™ Therapy System a promising treatment for gastroparesis?
What is the purpose of this trial?
The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures.Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at study visits.Participants will be involved in the study for up to six months after treatment assignment.Programming parameters in the study are within currently approved labeling.
Research Team
Abigail Stocker, MD
Principal Investigator
University of Louisville
Eligibility Criteria
This trial is for adults aged 18-70 with gastroparesis who already have the Enterra™ Therapy System implanted and are on stable medical therapy. They should not have cognitive impairments, other GI diseases that explain symptoms, severe night-time nausea/vomiting, or an irregular sleep schedule. Pregnant individuals or those planning pregnancy during the study are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to one of three Enterra® device programming methods active during sleep, with daily symptom tracking and quality of life assessments.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enterra™ Therapy System
Enterra™ Therapy System is already approved in United States for the following indications:
- Chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years
Find a Clinic Near You
Who Is Running the Clinical Trial?
Enterra Medical, Inc.
Lead Sponsor