Nausea, Vomiting
Conditions
Keywords
Chronic, Nausea, Vomiting, Gastric Electrical Stimulation
Brief summary
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.
Detailed description
Participants in this study will have an Enterra® Therapy System implanted and be assigned to a study group. Participants will answer daily questions about their nausea and vomiting symptoms and quality of life impacts with their smart device. Participants will answer quality of life questionnaires about their symptoms at study visits. Participants will be involved in this study for approximately twelve months after their study group is assigned.
Interventions
DEVICEEnterra Therapy System
The 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.
Sponsors
Enterra Medical, Inc.
Bright Research Partners
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Delegated site personnel will be unblinded to subject treatment assignments to appropriately program their Enterra Therapy System, per study requirements. Unblinded site personnel will be the only role delegated the responsibilities of randomizing subjects to a treatment assignment, performing device interrogations, and completing device programming at study visits according to the randomization assignment.
Intervention model description
Assigned to ON or OFF group. ON group receives active therapy immediately after treatment assignment; OFF group receives active therapy after four months of treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Patient is able to complete ANMS GCSI-DD surveys on a compatible smart device with: a) a minimum of four (4) ANMS GCSI-DD entries per week for two consecutive weeks, and b) an average ANMS GCSI-DD score for nausea severity of ≥2.5 during the same two-week period * Refractory or intolerant to two or more of the following antiemetic drug classes: antihistamines, phenothiazines, serotonin type 3 receptor antagonists, dopamine type 2 receptor antagonists, anticholinergics, neurokinin receptor antagonists * Medically stable, in the opinion of the investigator, during the month prior to consent, with no planned modifications to medical therapy during the course of the study * Normal gastric emptying as assessed by a qualifying gastric emptying test performed within 2 years of consent if no prior pyloric transection therapy, or within 2 years of consent and after the most recent pyloric transection therapy * Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum) performed within 1 year of consent if no prior pyloric transection therapy, or within 1 year of consent and after the most recent pyloric transection therapy
Exclusion criteria
* 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 * History of primary psychogenic vomiting * History of primary eating disorder * History of cyclic vomiting syndrome * History of rumination syndrome * History of scleroderma * History of amyloidosis * History of cannabis hyperemesis syndrome * Active H. pylori infection * Evidence of bezoar during most recent endoscopy * Previous gastric surgery of any type other than a pyloric transection therapy (i.e., pyloroplasty, pyloromyotomy, POP, or G-POEM) * Uncontrolled thyroid disorder, in the opinion of the investigator * History of seizures disorders * Hemoglobin A1c \>8.0% * Peritoneal dialysis or unstable hemodialysis * Parenteral or enteral nutritional support * Active pancreatitis * History of organ transplant, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease * Other GI tract diseases and disorders that the investigator believes may have caused the patient's drug-refractory nausea and/or vomiting * Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of consent * Opioid use * Current cannabis/cannabinoid use that exceeds: 3 days of usage per week, or 2 occurrences during each day of use, or 3 grams of total usage per week * Heavy alcohol use, defined as: for men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more drinks on any day or 8 or more per week * Injection of Botox into the pyloric sphincter within 6 months of consent * Active major levels of anxiety/depression, as determined by the investigator * History of other clinically significant disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact the validity of the study results * Life expectancy \<1 year * Pregnant or breastfeeding at the time of consent or intend to become pregnant during the study * Any underlying disease leading to follow-up by MRI outside of current MR conditional indications * Glucagon-like peptide 1 (GLP-1) agonist drug use within 6 months of consent * Participation in other investigational clinical studies * Existing or prior gastric electrical stimulator implantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nausea Severity Score | 4 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 | 4 Months | 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 | 12 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 | 4 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 | 12 Months | As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score |
| Change in Early Satiety Score | 4 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) early satiety score |
| Change in Abdominal Pain Score | 4 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) abdominal pain score |
| Change in Postprandial Fullness Score | 4 Months | As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) postprandial fullness score |
Countries
Belgium, France, Sweden, United Kingdom, United States
Contacts
CONTACTTimothy McAllister
CONTACTHannah Bearinger, PhD
STUDY_DIRECTORJason Hamann, PhD
Enterra Medical, Inc.
Outcome results
None listed