Status:
RECRUITING
Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Lead Sponsor:
Enterra Medical, Inc.
Conditions:
Gastroparesis
Gastroparesis Nondiabetic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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, a...
Eligibility Criteria
Inclusion
- 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 years at time of Enterra® therapy implantation
- Diagnosed with idiopathic or diabetic gastroparesis
- 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
- Investigator confirms normal endoscopy within one year of enrollment in the study
- 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
- Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator
- History of pyloroplasty or pyloromyotomy or G-POEM
- Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
- Active H. pylori infection
- Significant hepatic injury (elevated ALT, AST, bilirubin)
- 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
- Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
- Participation in other clinical studies
- 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)
- Cannabis and/or cannabinoid use that exceeds either:
- Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
- Greater than 3 grams of total usage per week
- Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
- Subject experiences discomfort during stimulation assessment that cannot be tolerated
- Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
- Evidence of a failed response to temporary gastric electrical stimulation
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06560307
Start Date
July 25 2024
End Date
December 1 2026
Last Update
November 15 2024
Active Locations (6)
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1
University of South Florida
Tampa, Florida, United States, 33620
2
University of Louisville
Louisville, Kentucky, United States, 40202
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Washington University
St Louis, Missouri, United States, 63110