Evaluating Enterra Device Programming for Gastroparesis Relief During Sleep
Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
This study is testing different ways to program the Enterra® device at night to see if it helps people with gastroparesis feel better while they sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Enterra Medical, Inc. Industry-sponsored |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT05980455 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of different programming methods for the Enterra® device during nighttime in patients with gastroparesis. Participants who already have the Enterra® device implanted will be randomly assigned to one of three programming methods that operate while they sleep. They will report their symptoms daily through a mobile application and complete quality of life questionnaires during study visits. The study duration for each participant is up to six months, focusing on symptom relief and quality of life improvements.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 who have a stable gastroparesis condition and are already implanted with the Enterra® Therapy System.
Not a fit: Patients who do not have the Enterra® device or those with unstable gastroparesis symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance symptom management and quality of life for patients with gastroparesis.
How similar studies have performed: While similar approaches have been explored, this specific programming method during sleep is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to be eligible to participate in this study, a participant must meet all of the following criteria: 1. Completed informed consent process with signed and dated informed consent form; 2. Stated willingness to comply with all study procedures and availability for the duration of the study; 3. Male or female, aged ≥18 or ≤70 at time of informed consent; 4. Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator); 5. High GES output defined as remaining pulse generator expected life of \> 9 months from enrollment and less than 4 years from the time of implant; 6. Stable gastroparesis symptoms, in the opinion of the investigator; 7. On stable medical therapy for gastroparesis symptoms; 8. On stable supplemental nutritional support during the month prior to enrollment; 9. English language comprehension to complete study-required assessments; 10. Reliable access to internet-connected smart device(s) to complete study-required assessments. A participant who meets any of the following criteria will be excluded from participation in this study: 1. Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator; 2. Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night; 3. Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning; 4. Subjects without a regular and defined sleep schedule; 5. Pregnancy, or subject that intends to become pregnant during participation in the study; 6. Chemical dependency; 7. Enterra lead impedance measurements ≥ 700 Ohms at screening visit; 8. Life expectancy \< 1 year from conditions other than GI diseases; 9. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications; 10. Participation in other clinical studies; 11. Subjects involved in current or past medical-related litigation; 12. Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.
Where this trial is running
Louisville, Kentucky and 1 other locations
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- MNGI Digestive Health, P.A. — Coon Rapids, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Abigail Stocker, MD — University of Louisville
- Study coordinator: Timothy McAllister
- Email: clinicalresearch@enterramedical.com
- Phone: 855-768-3772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.