144
Participants
Start Date
March 23, 2018
Primary Completion Date
August 17, 2021
Study Completion Date
March 17, 2022
Cryoneurolysis
Cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
Sham Comparator
Sham cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. However, for sham probes, the nitrous oxide is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis.
Walter Reed National Military Medical Center, Bethesda
University of Florida, Gainesville
Cleveland Clinic, Cleveland
University California San Diego, San Diego
Naval Medical Center San Diego (NMCSD), San Diego
Veterans Affairs Palo Alto Health Care System, Palo Alto
United States Department of Defense
FED
University of California, San Diego
OTHER