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A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra Therapy System
Led by Enterra Medical, Inc. · Updated on 2026-05-14
148
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Enterra Medical, Inc.
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates whether the Enterra Therapy System can reduce nausea and vomiting symptoms and improve quality of life in patients who experience chronic nausea with normal gastric emptying. The study focuses on patients whose symptoms have been persistent, drug-resistant, and active recently, aiming to assess the device's impact on these symptoms over time. Participants will have the Enterra Therapy System implanted, a gastric electrical stimulator consisting of an implantable pulse generator and leads, programmed and adjusted by clinicians. They will be randomly assigned to one of two groups: an ON group receiving initial device stimulation, or an OFF group starting with the device turned off and later switched on. Adjustments to device programming will occur at follow-up visits, with individualized therapy settings introduced after initial study periods. Throughout about twelve months of participation, patients will regularly report their nausea and vomiting symptoms and quality of life impacts using a smart device and complete questionnaires during study visits. Researchers will monitor changes in nausea severity, vomiting frequency, total symptom scores, and quality of life scores at 4 and 12 months. This ongoing assessment helps evaluate the effects of the therapy system while ensuring patient safety and adherence to study protocols.
CONDITIONS
Brief Title
Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to complete the informed consent process
- Willing to comply with all study procedures and available for the study duration
- Aged 18 years or older at time of consent
- Chronic, drug-resistant nausea lasting more than 6 months and active within the last 3 months
- Able to complete at least four symptom survey entries per week for two consecutive weeks on a compatible smart device
- Average nausea severity score of 2.5 or higher during the two-week survey period
- Refractory or intolerant to two or more antiemetic drug classes
- Medically stable with no planned changes in medical therapy during the study
- Normal gastric emptying test within 2 years prior to consent
- Normal upper endoscopy within 1 year prior to consent
You will not qualify if you...
- Cognitive impairment or other issues limiting ability to complete study requirements
- Pyloric transection therapy within 1 year of consent
- Documented gastrointestinal 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 in recent endoscopy
- Previous gastric surgery other than pyloric transection therapy
- Uncontrolled thyroid disorder
- History of seizure disorders
- Hemoglobin A1c above 8.0%
- Receiving peritoneal dialysis or unstable hemodialysis
- Receiving parenteral or enteral nutritional support
- Active pancreatitis
- History of organ transplant, malabsorption syndromes, celiac disease, or inflammatory bowel disease
- Other gastrointestinal diseases causing drug-refractory nausea or vomiting
- Current or recent malignancy within 5 years except basal cell carcinoma
- Opioid use
- Excessive cannabis/cannabinoid use
- Heavy alcohol use
- Botox injection into pyloric sphincter within 6 months
- Active major anxiety or depression
- Other significant disease impacting safety or study validity
- Life expectancy less than 1 year
- Pregnant or breastfeeding or intending pregnancy during the study
- Underlying disease requiring MRI follow-up beyond current device safety
- Use of GLP-1 agonist drugs within 6 months
- Participation in other investigational studies
- Prior gastric electrical stimulator implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have the Enterra Therapy System implanted and are assigned to a study group with device programming settings.
1 in-person implantation visit
Duration - Up to 12 months
Participants receive programmed device stimulation with adjustments during follow-up visits. ON group receives active stimulation from the start; OFF group device programmed off initially, then activated after 4 months.
Regular follow-up visits with device programming adjustments; participants answer daily symptom questions via smart device and complete quality of life questionnaires at study visits
Trial Site Locations
Total: 22 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Keck Medicine of USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
Hoag Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
4
Sutter Health
San Francisco, California, United States, 94109
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
6
Endeavor Health
Evanston, Illinois, United States, 60201
Actively Recruiting
7
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
9
Hackensack Meridian
Neptune City, New Jersey, United States, 07753
Actively Recruiting
10
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
Temple Digestive Disease Center
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
13
UZ Leuven
Leuven, Belgium
Actively Recruiting
14
Hôpital Louis-Mourier
Colombes, France
Actively Recruiting
15
Hôpital Edouard Herriot - CHU de Lyon
Lyon, France, 69003
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16
CHU de Bordeaux
Pessac, France
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17
CHU de Rouen
Rouen, France, 76031
Actively Recruiting
18
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 413 45
Actively Recruiting
19
University College London Hospital
London, United Kingdom, NW1 6DB
Actively Recruiting
20
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
21
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M23 9LT
Actively Recruiting
22
Functional Gut Clinic
Manchester, United Kingdom, M3 4BG
Actively Recruiting
Research Team
T
Timothy McAllister
H
Hannah Bearinger, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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