Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Recruiting
N/A
Interventional Study
Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Enterra Medical, Inc. · Industry
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About This Trial
The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures.
Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programmin…
Trial Locations
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Eligibility Criteria
Inclusion 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 years at time of Enterra® therapy implantation
4. Diagnos…
Contacts