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The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures.
Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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 Sleep Cycle | Active Comparator | Baseline device programming parameters will be used during study participation. No modification to Enterra® device programming will be in effect during waking or sleeping hours. |
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| Arm 1 Sleep Cycle | Experimental | Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra® device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra® device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra® device will return to waking hours programming. |
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| Arm 2 Sleep Cycle | Experimental | Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra® device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra® device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra® device will return to waking hours programming. |
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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 |
|---|---|---|
| Percent Change in Weekly Vomiting Frequency by GCSI-DD | Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline | 3 Months, 6 Months |
| Scoring Change in Nausea Severity by GCSI-DD | Less than a 1-point increase in GCSI-DD nausea severity from baseline | 3 Months, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in GCSI-DD Total Symptom Score | Change in GCSI-DD Total Symptom Score from baseline | 3 Months, 6 Months |
| Mean Change from Baseline in GCSI-DD Nausea Severity | Change in GCSI-DD nausea severity from baseline |
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In order to be eligible to participate in this study, a participant must meet all of the following criteria:
A participant who meets any of the following criteria will be excluded from participation in this study:
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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 |
|---|---|---|
| Abigail Stocker, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | 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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|
|
| 3 Months, 6 Months |
| Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency | Change in GCSI-DD weekly vomiting frequency from baseline | 3 Months, 6 Months |
| Mean Change from Baseline in PAGI-QoL Scores | Change in PAGI-QoL from baseline | 3 Months, 6 Months |
| Mean Change from Baseline in Quality of Sleep Scores | Change in Quality of Sleep from baseline | 3 Months, 6 Months |
| MNGI Digestive Health, P.A. | Recruiting | Coon Rapids | Minnesota | 55433 | United States |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |