NCT06560307 Study of Enhanced Programming Stimulation with the Enterra® Therapy System
| NCT ID | NCT06560307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Enterra Medical, Inc. |
| Condition | Gastroparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-07-25 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Eligibility 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
Contact & Investigator
Michael Awad, MD, PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06560307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06560307 currently recruiting?
Yes, NCT06560307 is actively recruiting participants. Contact the research team at clinicalresearch@enterramedical.com for enrollment information.
Where is the NCT06560307 trial being conducted?
This trial is being conducted at Tampa, United States, Louisville, United States, Detroit, United States, St Louis, United States and 2 additional locations.
Who is sponsoring the NCT06560307 clinical trial?
NCT06560307 is sponsored by Enterra Medical, Inc.. The principal investigator is Michael Awad, MD, PhD at Washington University School of Medicine. The trial plans to enroll 50 participants.