An interventional study of Enterra Therapy System in Gastroparesis, Gastroparesis Nondiabetic and Gastroparesis Due to Diabetes Mellitus, sponsored by Enterra Medical, Inc.. Recruiting at 6 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Enterra Medical, Inc. · Not applicable, Interventional, and Treatment
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.
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 202 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Enterra Medical, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cannabis and/or cannabinoid use that exceeds either:
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.
Device: Enterra Therapy System
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.
Device: Enterra 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.
Also known as: Gastric electrical stimulation
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
Time frame: 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
Time frame: 3 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
Time frame: 6 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
Time frame: 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
Time frame: 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
Time frame: 6 Months
Change in Quality of Life Score
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
Time frame: 3 Months
Change in Quality of Life Score
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
Time frame: 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
Time frame: 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
Time frame: 1 Month
Plan to share: No
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Enterra Medical, Inc.