Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

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.