Actively Recruiting
Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
Led by Enterra Medical, Inc. · Updated on 2026-05-14
148
Participants Needed
22
Research Sites
257 weeks
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
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.
CONDITIONS
Official 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 follow all study procedures and be available for the study duration
- Aged 18 years or older at consent
- Have chronic, drug-resistant nausea present for more than 6 months and active within the last 3 months
- Able to complete at least four ANMS GCSI-DD symptom surveys per week for two consecutive weeks on a smart device
- Have an average nausea severity score of 2.5 or higher on these surveys during the two weeks
- Have been intolerant or refractory to two or more types of antiemetic drugs
- Medically stable with no planned changes to medical therapy in the month before consent
- Have normal gastric emptying confirmed by testing within 2 years
- Have had a normal upper endoscopy within 1 year prior to consent
You will not qualify if you...
- Cognitive or other impairments limiting ability to complete study requirements
- Pyloric transection therapy within 1 year of consent
- Gastrointestinal obstruction or pseudo-obstruction
- History of primary swallowing disorders, psychogenic vomiting, eating disorders, cyclic vomiting syndrome, rumination syndrome, scleroderma, amyloidosis, or cannabis hyperemesis syndrome
- Active H. pylori infection or presence of bezoar on recent endoscopy
- Previous gastric surgery other than pyloric transection
- Uncontrolled thyroid disorder
- History of seizure disorders
- Hemoglobin A1c over 8.0%
- On peritoneal dialysis or unstable hemodialysis
- Receiving parenteral or enteral nutrition
- Active pancreatitis
- History of organ transplant, malabsorption, celiac disease, or inflammatory bowel disease
- Other gastrointestinal diseases possibly causing nausea or vomiting
- Current cancer diagnosis or cancer within 5 years except basal cell carcinoma
- Use of opioids or high cannabis/cannabinoid use
- Heavy alcohol use as defined by gender-specific drink limits
- Botox injection into pyloric sphincter within 6 months
- Active major anxiety or depression
- Other significant diseases or conditions that may affect safety or study validity
- Life expectancy less than 1 year
- Pregnant, breastfeeding, or planning pregnancy during the study
- Conditions preventing MRI follow-up
- Use of GLP-1 agonist drugs within 6 months
- Participation in other clinical studies
- Previous gastric electrical stimulator implantations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
16
CHU de Bordeaux
Pessac, France
Actively Recruiting
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
CONTACT
H
Hannah Bearinger, PhD
CONTACT
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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