Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
Recruiting now · Not applicable
Conditions studied: Nausea, Vomiting
In brief
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.
Key facts
- Study ID
- NCT06464926
- Run by
- Enterra Medical, Inc.
- People needed
- 148
- Starts
- 2025-06-23
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
- Keck Medicine of USC — Los Angeles, California, United States (enrolling)
- Hoag Hospital — Newport Beach, California, United States (enrolling)
- Sutter Health — San Francisco, California, United States (enrolling)
- University of South Florida — Tampa, Florida, United States (enrolling)
- Endeavor Health — Evanston, Illinois, United States (enrolling)
- Indiana University Health — Indianapolis, Indiana, United States (enrolling)
- University of Louisville — Louisville, Kentucky, United States (enrolling)
- Hackensack Meridian — Neptune City, New Jersey, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Temple Digestive Disease Center — Philadelphia, Pennsylvania, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- UZ Leuven — Leuven, Belgium (enrolling)
- Hôpital Louis-Mourier — Colombes, France (enrolling)
- Hôpital Edouard Herriot - CHU de Lyon — Lyon, France (enrolling)
- CHU de Bordeaux — Pessac, France (enrolling)
- CHU de Rouen — Rouen, France (enrolling)
- Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (enrolling)
- University College London Hospital — London, United Kingdom (enrolling)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (enrolling)
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (enrolling)
- Functional Gut Clinic — Manchester, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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