100
Participants
Start Date
August 30, 2023
Primary Completion Date
December 1, 2024
Study Completion Date
August 1, 2025
Cryoneurolysis
The VISUAL-ICE uses a combination of argon and helium, to create a highly localized cold zone with temperatures between -20 and -100°C. A probe will be inserted percutaneously at the target AFCN and IBSN guided by ultrasound visualization to accurately determine the location of the nerve and to account for adjacent neurovascular structures and variations in anatomical structures. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Cryoneurolysis at each target site requires 2 freeze cycles with a duration of 3 mins, and with thaw cycles between 20-40 seconds.
Sham
A sham needles will be inserted percutaneously at the target AFCN and IBSN guided by ultrasound visualization. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Sham will simulate cryoneurolysis at each target site for 2 freeze cycles with a duration of 3 mins, and also simulate thaw cycles between 20-40 seconds. No temperature changes will actually occur although the experience and sounds will be similar to cryoneurolysis
RECRUITING
Hospital of Southwest Jutland, Esbjerg
Collaborators (1)
Odense University Hospital
OTHER
Boston Scientific Corporation
INDUSTRY
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER