Gastroparesis, Gastroparesis Due to Diabetes Mellitus, Gastroparesis Nondiabetic
Conditions
Keywords
Gastric electrical stimulation, Gastroparesis
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.
Interventions
DEVICEEnterra 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.
Sponsors
Enterra Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vomiting Absolute Frequency | 3 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency |
| Change in Nausea Severity Score | 3 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vomiting Absolute Frequency | 6 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency |
| Change in Nausea Severity Score | 6 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score |
| Change in Total Symptom Score | 3 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score |
| Change in Quality of Life Score | 3 Months | As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score |
Countries
United States
Contacts
Primary ContactTimothy McAllister
Backup ContactJason Hamann, PhD
Outcome results
None listed