Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

February 12, 2024

Primary Completion Date

October 9, 2025

Study Completion Date

October 9, 2025

Conditions
Amputation, SurgicalAmputation, TraumaticPhantom Limb PainPhantom Pain Following Amputation of Lower Limb
Interventions
DEVICE

ACTIVE cryoneurolysis

Cryoneurolysis of the major nerves of the thigh (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium Initial treatment: Cryoneurolysis of the major nerves of the thigh (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.

DEVICE

SHAM cryoneurolysis

SHAM cryoneurolysis of the major nerves of the thigh (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.

Trial Locations (1)

92037

University of California San Diego, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Varian Medical Systems

INDUSTRY

lead

University of California, San Diego

OTHER