Actively Recruiting
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Led by Enterra Medical, Inc. · Updated on 2024-11-15
50
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed informed consent with signed and dated form
- Willing to comply with all study procedures and available for the study duration
- Male or female aged 18 to 70 years at consent
- Currently implanted with Enterra4 Therapy System (Enterra4 II 37800 neurostimulator)
- High device output with expected pulse generator life over 9 months and less than 4 years since implant
- Stable gastroparesis symptoms as judged by the investigator
- On stable medical therapy for gastroparesis symptoms
- On stable supplemental nutritional support for at least 1 month prior to enrollment
- Able to understand English to complete study assessments
- Reliable access to internet-connected smart device(s) to complete study assessments
You will not qualify if you...
- Post-surgical gastroparesis or other active stomach/GI disorders explaining symptoms as per investigator
- Severe nausea and/or vomiting at night as judged by investigator
- Severe gastroparesis symptoms upon waking as judged by investigator
- Lack of a regular and defined sleep schedule
- Pregnancy or intending to become pregnant during the study
- Chemical dependency
- Enterra lead impedance 63 700 Ohms at screening
- Life expectancy less than 1 year from non-GI conditions
- Underlying disease requiring MRI follow-up outside current MR conditional indications
- Participation in other clinical studies
- Current or past medical-related litigation involvement
- Cognitive impairment or other limitation affecting ability to complete study requirements
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
MNGI Digestive Health, P.A.
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
Research Team
T
Timothy McAllister
CONTACT
J
Jason Hamann, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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