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

NARecruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

June 23, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2030

Conditions
NauseaVomiting
Interventions
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."

Trial Locations (10)

19140

RECRUITING

Temple Digestive Disease Center, Philadelphia

33606

RECRUITING

University of South Florida, Tampa

40202

RECRUITING

University of Louisville, Louisville

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

46202

RECRUITING

Indiana University Health, Indianapolis

76031

RECRUITING

CHU de Rouen, Rouen

85259

RECRUITING

Mayo Clinic Arizona, Scottsdale

94109

RECRUITING

Sutter Health, San Francisco

Unknown

RECRUITING

UZ Leuven, Leuven

RECRUITING

Hôpital Louis-Mourier, Colombes

Sponsors
All Listed Sponsors
collaborator

Bright Research Partners

INDUSTRY

lead

Enterra Medical, Inc.

INDUSTRY

NCT06464926 - Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) | Biotech Hunter | Biotech Hunter