About this trial
The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to complete the informed consent process
Stated willingness to comply with all study procedures and availability for the duration of the study
Aged ≥18 years at time of informed consent
Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent
Disqualifiers
Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements
Pyloric transection therapy completed within 1 year of consent
Documented gastrointestinal (GI) obstruction or pseudo-obstruction
History of primary swallowing disorders
Trial design
Parallel
Treatments tested in this trial
Enterra Therapy System
DeviceThe Enterra Therapy System is a gastric electrical stimulator system consisting of an implantable pulse generator (Enterra II Model 37800 neurostimulator); two implantable unipolar leads (Enterra Model 4351-35 intramuscular); and device programmer (N'Vision Clinician Programmer Model 8840 with Model 8870 Application Card). The programmable neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation through the implanted lead system. A clinician programmer is used to program the neurostimulator and adjust stimulation settings to programmable parameters and stimulation options.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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. Analysis only performed if ≥64 evaluable participants have a baseline weekly vomiting frequency of ≥5 per week
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
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. Analysis only performed if ≥64 evaluable participants have a baseline weekly vomiting frequency of ≥5 per week
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
Sponsors and contacts
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Enterra Medical, Inc.
Lead sponsor
Bright Research Partners
Collaborator