Study of Enhanced Programming Stimulation with the Enterra® Therapy System
NCT ID: NCT06560307
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-07-25
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control Programming Stimulation
Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, nominal programming will continue. Slight increases in device amplitude (stimulation) will be done at 3 Month visit and at later follow-up visits.
Enterra Therapy System
The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Enhanced Programming Stimulation
Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, moderate increases in device amplitude (stimulation) and duty cycle (on/off cycles) will be done. Further adjustments to amplitude, duty cycle, and/or frequency (rate of pulses) will be done at follow-up visits.
Enterra Therapy System
The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Interventions
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Enterra Therapy System
The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Diagnosed with idiopathic or diabetic gastroparesis
5. Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as \> 60% retained at 2 hours and/or \>10% retained at 4 hours
6. Investigator confirms normal endoscopy within one year of enrollment in the study
7. GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week
Exclusion Criteria
2. History of pyloroplasty or pyloromyotomy or G-POEM
3. Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
4. Active H. pylori infection
5. Significant hepatic injury (elevated ALT, AST, bilirubin)
6. Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
7. Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
8. Participation in other clinical studies
9. Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)
10. Cannabis and/or cannabinoid use that exceeds either:
1. Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
2. Greater than 3 grams of total usage per week
11. Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
12. Subject experiences discomfort during stimulation assessment that cannot be tolerated
13. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
14. Evidence of a failed response to temporary gastric electrical stimulation
18 Years
70 Years
ALL
No
Sponsors
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Enterra Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Awad, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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University of South Florida
Tampa, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Foundation for Surgical Innovation
Portland, Oregon, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Joseph Sujka, MD
Role: backup
Amy Perdue
Role: primary
Abigail Stocker, MD
Role: backup
Kellie McFarlin, MD
Role: backup
Asima Badic
Role: primary
Michael Awad, MD, PhD
Role: backup
Angi Gill
Role: primary
Christy Dunst, MD
Role: backup
Cheryl Shaw
Role: primary
Pierre Blais, MD
Role: backup
Other Identifiers
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CLN 001-PR-01218
Identifier Type: -
Identifier Source: org_study_id
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