Enhanced programming stimulation for gastroparesis treatment
Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation
NA · Enterra Medical, Inc. · NCT06560307
This study is testing if a new way of programming a device for treating gastroparesis can help people feel better and improve their quality of life faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Enterra Medical, Inc. (industry) |
| Locations | 6 sites (Tampa, Florida and 5 other locations) |
| Trial ID | NCT06560307 on ClinicalTrials.gov |
What this trial studies
This research evaluates whether an enhanced programming strategy for the Enterra Therapy System can improve symptoms of gastroparesis more quickly and enhance quality of life. Participants will have the device implanted and will be randomly assigned to one of two programming strategies. They will track their symptoms daily using a mobile application and complete quality of life questionnaires during monthly visits. The study will last up to six months post-treatment assignment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with idiopathic or diabetic gastroparesis.
Not a fit: Patients with post-surgical gastroparesis or other gastrointestinal disorders that explain their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate symptoms and improve the quality of life for patients suffering from gastroparesis.
How similar studies have performed: Other studies have shown promise with gastric electrical stimulation, suggesting potential for success with this enhanced programming approach.
Eligibility criteria
Show full inclusion / exclusion 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. 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:
1. 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
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
Where this trial is running
Tampa, Florida and 5 other locations
- University of South Florida — Tampa, Florida, United States (RECRUITING)
- University of Louisville — Louisville, Kentucky, United States (RECRUITING)
- Henry Ford Health System — Detroit, Michigan, United States (RECRUITING)
- Washington University — St Louis, Missouri, United States (RECRUITING)
- Foundation for Surgical Innovation — Portland, Oregon, United States (RECRUITING)
- Benaroya Research Institute at Virginia Mason — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Awad, MD, PhD — Washington University School of Medicine
- Study coordinator: Timothy McAllister
- Email: clinicalresearch@enterramedical.com
- Phone: 855-768-3772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus, Gastric electrical stimulation