Evaluating Enterra Device Programming for Gastroparesis Relief During Sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.