Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Purpose
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
- Gastroparesis
- Gastroparesis Nondiabetic
- Gastroparesis Due to Diabetes Mellitus
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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. |
|
|
Experimental 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. |
|
Recruiting Locations
University of South Florida
Tampa, Florida 33620
Tampa, Florida 33620
University of Louisville
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Amy Perdue
Amy Perdue
Henry Ford Health System
Detroit, Michigan 48202
Detroit, Michigan 48202
Washington University
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Contact:
Asima Badic
Asima Badic
Foundation for Surgical Innovation
Portland, Oregon 97213
Portland, Oregon 97213
Contact:
Angi Gill
Angi Gill
Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
Seattle, Washington 98101
Contact:
Cheryl Shaw
Cheryl Shaw
More Details
- NCT ID
- NCT06560307
- Status
- Recruiting
- Sponsor
- Enterra Medical, Inc.