99
Participants
Start Date
August 25, 2018
Primary Completion Date
January 7, 2022
Study Completion Date
November 25, 2022
Cryoneurolysis (active)
Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle. Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
Sham cryoneurolysis procedure
"Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.~Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature"
UCSD Medical Center, San Diego
Collaborators (2)
Epimed International
INDUSTRY
Pacira Pharmaceuticals, Inc
INDUSTRY
University of California, San Diego
OTHER