Status:
RECRUITING
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Lead Sponsor:
Enterra Medical, Inc.
Conditions:
Gastroparesis
Gastroparesis Nondiabetic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 me...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05980455
Start Date
July 10 2023
End Date
December 1 2025
Last Update
November 15 2024
Active Locations (2)
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1
University of Louisville
Louisville, Kentucky, United States, 40202
2
MNGI Digestive Health, P.A.
Coon Rapids, Minnesota, United States, 55433