ClinicaliQ Trial Snapshot
- Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT06464926.
- What is being tested: The Enterra® Therapy System (gastric electrical stimulation device) is being evaluated for its efficacy in reducing chronic nausea and vomiting symptoms in patients with normal gastric emptying, addressing a patient population currently lacking evidence-based treatment options.
- Patient eligibility overview: The trial targets patients with chronic nausea with or without vomiting who have documented normal gastric emptying (distinguishing them from gastroparesis patients), representing a clinically distinct group with limited therapeutic alternatives.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.