Enterra Programming for Gastroparesis
(RESTING Trial)
What You Need to Know Before You Apply
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.
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.
Is Enterra Therapy safe for humans?
Is the Enterra™ Therapy System a promising treatment for gastroparesis?
What data supports the effectiveness of the treatment Enterra Therapy System for gastroparesis?
Who Is on the Research Team?
Abigail Stocker, MD
Principal Investigator
University of Louisville
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Enterra™ Therapy System
Enterra™ Therapy System is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Enterra Medical, Inc.
Lead Sponsor