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:

• Completed informed consent process with signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Male or female, aged ≥18 or ≤70 at time of informed consent;
• Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);
• 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;
• Stable gastroparesis symptoms, in the opinion of the investigator;
• On stable medical therapy for gastroparesis symptoms;
• On stable supplemental nutritional support during the month prior to enrollment;
• English language comprehension to complete study-required assessments;
• 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:

• 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;
• Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night;
• Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;
• Subjects without a regular and defined sleep schedule;
• Pregnancy, or subject that intends to become pregnant during participation in the study;
• Chemical dependency;
• Enterra lead impedance measurements ≥ 700 Ohms at screening visit;
• Life expectancy < 1 year from conditions other than GI diseases;
• Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;
• Participation in other clinical studies;
• Subjects involved in current or past medical-related litigation;
• Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.