Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study

NACompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

March 23, 2018

Primary Completion Date

August 17, 2021

Study Completion Date

March 17, 2022

Conditions
Post-Amputation Phantom Limb Pain
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (6)

20889

Walter Reed National Military Medical Center, Bethesda

32610

University of Florida, Gainesville

44195

Cleveland Clinic, Cleveland

92103

University California San Diego, San Diego

92134

Naval Medical Center San Diego (NMCSD), San Diego

94304

Veterans Affairs Palo Alto Health Care System, Palo Alto

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

University of California, San Diego

OTHER

NCT03449667 - Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study | Biotech Hunter | Biotech Hunter