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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Programming Stimulation | Active Comparator | 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. |
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| Enhanced Programming Stimulation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterra Therapy System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vomiting Absolute Frequency | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency | 3 Months |
| Change in Nausea Severity Score | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vomiting Absolute Frequency | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency | 6 Months |
| Change in Nausea Severity Score |
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Inclusion Criteria:
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
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy McAllister | Contact | 855-768-3772 | clinicalresearch@enterramedical.com | |
| Jason Hamann, PhD | Contact | 855-768-3772 | clinicalresearch@enterramedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Awad, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33620 | United States |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score |
| 6 Months |
| Change in Total Symptom Score | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score | 3 Months |
| Change in Total Symptom Score | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score | 6 Months |
| Change in Quality of Life Score | As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score | 3 Months |
| Change in Quality of Life Score | As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score | 6 Months |
| Change in Vomiting Absolute Frequency | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency | 1 Month |
| Change in Nausea Severity Score | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score | 1 Month |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Foundation for Surgical Innovation | Recruiting | Portland | Oregon | 97213 | United States |
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| Benaroya Research Institute at Virginia Mason | Recruiting | Seattle | Washington | 98101 | United States |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |