Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEnterra Medical, Inc.
About this trial
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 measures.
Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at study visits.
Participants will be involved in the study for up to six months after treatment assignment.
Programming parameters in the study are within currently approved labeling.
Eligibility criteria
Qualifiers
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);
Disqualifiers
None
Trial design
Treatments tested in this trial
- Enterra® Therapy System
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov