NAVIGATE
Research type
Research Study
Full title
A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients with Normal Gastric Emptying using the Enterra® Therapy System (NAVIGATE) ENT-CL-5000
IRAS ID
348619
Contact name
Jason Haman
Contact email
Sponsor organisation
Enterra Medical Inc.
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-24-11-049817, CIV-ID/EUDAMED
Duration of Study in the UK
3 years, 0 months, 5 days
Research summary
The Enterra Therapy System is a small, implantable medical device that sends electrical pulses to the stomach. It includes a pulse generator (similar to a pacemaker), two thin wires (leads) that deliver the stimulation, and a programmer that adjusts the settings. This system may reduce nausea and vomiting, improve patients' daily lives, and offer a new treatment option for those who have not found relief with medication.
To test its effectiveness, the study will follow a randomized, double-blind design. This means that participants will be randomly assigned to different groups, and neither they nor their doctors will know who is receiving active stimulation and who is receiving a non-active version during the initial phase of the study. This approach helps ensure that the results are reliable and unbiased.
Participants will be involved in the study for 12 months after being assigned to a treatment group. During this time, they will undergo regular medical assessments and symptom monitoring to evaluate the effects of the therapy.
The study is funded by Enterra Medical, Inc. and will take place at up to 15 sites in the U.S. and up to 8 sites in the United Kingdom, France, Belgium, and Sweden.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0152
Date of REC Opinion
20 Oct 2025
REC opinion
Further Information Favourable Opinion