NCT06464926

Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)

A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Enterra Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants in this study will have an Enterra® Therapy System implanted and be assigned to a study group. Participants will answer daily questions about their nausea and vomiting symptoms and quality of life impacts with their smart device. Participants will answer quality of life questionnaires about their symptoms at study visits. Participants will be involved in this study for approximately twelve months after their study group is assigned.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DEVICE	Enterra Therapy System	The Enterra Therapy System is a gastric electrical stimulator system consisting of an implantable pulse generator (Enterra II Model 37800 neurostimulator); two implantable unipolar leads (Enterra Model 4351-35 intramuscular); and device programmer (N'Vision Clinician Programmer Model 8840 with Model 8870 Application Card). The programmable neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation through the implanted lead system. A clinician programmer is used to program the neurostimulator and adjust stimulation settings to programmable parameters and stimulation options.

Timeline

• Start date: 2025-06-23
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2024-06-18
• Last updated: 2026-04-13

Locations

20 sites across 5 countries: United States, Belgium, France, Sweden, United Kingdom

Regulatory

• FDA-regulated device study