148
Participants
Start Date
June 23, 2025
Primary Completion Date
June 30, 2030
Study Completion Date
June 30, 2030
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."
RECRUITING
Temple Digestive Disease Center, Philadelphia
RECRUITING
University of South Florida, Tampa
RECRUITING
University of Louisville, Louisville
RECRUITING
Cleveland Clinic Foundation, Cleveland
RECRUITING
Indiana University Health, Indianapolis
RECRUITING
CHU de Rouen, Rouen
RECRUITING
Mayo Clinic Arizona, Scottsdale
RECRUITING
Sutter Health, San Francisco
RECRUITING
UZ Leuven, Leuven
RECRUITING
Hôpital Louis-Mourier, Colombes
Lead Sponsor
Bright Research Partners
INDUSTRY
Enterra Medical, Inc.
INDUSTRY