Actively Recruiting
Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Led by Enterra Medical, Inc. · Updated on 2024-11-15
50
Participants Needed
6
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 programming strategies. 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 monthly 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 Enhanced Programming Stimulation with the Enterra® Therapy System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to comply with all study procedures and be available for the study duration
- Male or female aged 18 to 70 years at therapy implantation
- Diagnosed with idiopathic or diabetic gastroparesis
- Delayed gastric emptying confirmed by Eggbeaters test within one year
- Normal endoscopy confirmed within one year
- Nausea severity score averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week during baseline period
You will not qualify if you...
- Post-surgical gastroparesis or other active gastrointestinal diseases explaining symptoms
- History of pyloroplasty, pyloromyotomy, or G-POEM
- Pregnancy, breastfeeding, or intent to become pregnant during the study
- Active Helicobacter pylori infection
- Significant liver injury (elevated ALT, AST, bilirubin)
- Other metabolic, mechanical, or inflammatory causes explaining symptoms
- Significant cardiac, cardiovascular disease, malignancy, or other serious conditions
- Participation in other clinical studies
- Use of narcotics more than three days per week or drugs affecting motility
- Excessive cannabis or cannabinoid use beyond specified limits
- History of orthostatic intolerance conditions like POTS or orthostatic hypotension
- Discomfort during stimulation assessment that cannot be tolerated
- Underlying disease requiring MRI follow-up outside current MR conditional guidelines
- Failed response to temporary gastric electrical stimulation
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
2
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Foundation for Surgical Innovation
Portland, Oregon, United States, 97213
Actively Recruiting
6
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
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
2
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