Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery

NAEnrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 5, 2025

Primary Completion Date

April 1, 2026

Study Completion Date

April 15, 2026

Conditions
Rotator Cuff TearsShoulder InjuriesHallux ValgusAnkle ArthropathyClavicle Fracture
Interventions
DEVICE

Experimental Treatment

Percutaneous peripheral nerve stimulation with a frequency of 100 Hz, a pulse duration of 100 µs, and a current amplitude of 0.001-10 mA (1-10,000 µA). Participants will adjust the amplitude, as needed.

DEVICE

Sham Comparator

SHAM percutaneous peripheral nerve stimulation with a frequency of 100 Hz, a pulse duration of 100 µs, and a current amplitude of 0.001-10 mA (1-10,000 µA). Participants can adjust the amplitude, as needed; but no electrical current will ever reach the patient's body.

Trial Locations (1)

92137

University of California San Diego, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gate Science

INDUSTRY

lead

University of California, San Diego

OTHER

NCT07052721 - Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery | Biotech Hunter | Biotech Hunter