Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
NCT ID: NCT06464926
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
148 participants
INTERVENTIONAL
2025-06-23
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ON Group
Participants assigned to the ON treatment group will begin with specified device programming values at the randomization visit. Device programming values may be adjusted at follow-up study visits during the blinding period.
At the conclusion of the 4-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. Investigators may adjust programming values at additional follow-up study visits.
Enterra 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.
OFF Group
Participants assigned to the OFF treatment group will begin with device programming values set to off at the randomization visit. These settings will continue until the 4-month visit.
At the conclusion of the 4-month visit, participants will receive specified device programming values. Device programming values may be adjusted at follow-up study visits. At the conclusion of the 8-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator.
Enterra 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.
Interventions
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Enterra 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bright Research Partners
INDUSTRY
Enterra Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Hamann, PhD
Role: STUDY_DIRECTOR
Enterra Medical, Inc.
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Sutter Health
San Francisco, California, United States
University of South Florida
Tampa, Florida, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Temple Digestive Disease Center
Philadelphia, Pennsylvania, United States
UZ Leuven
Leuven, , Belgium
Hôpital Louis-Mourier
Colombes, , France
Hôpital Edouard Herriot - CHU de Lyon
Lyon, , France
CHU de Rouen
Rouen, , France
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Aubrey Smith
Role: primary
Alexandria Ramirez
Role: backup
Stefanie Roberts
Role: primary
Christie Linh
Role: backup
Ilexsius Fiorillo
Role: primary
Beth Montera
Role: backup
Maureen Schilling
Role: primary
Amy Perdue, RN
Role: primary
Abigail Stocker, MD
Role: backup
Sara Valencia
Role: primary
Madison Tieben
Role: backup
Alexis Bailey
Role: primary
Other Identifiers
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ENT-CL-5000
Identifier Type: -
Identifier Source: org_study_id