NCT05154448View on ClinicalTrials.gov

Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 16, 2022

Primary Completion Date

April 16, 2024

Study Completion Date

April 16, 2024

Conditions
Facet Syndrome of Lumbar Spine
Interventions
DEVICE

Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

OTHER

Sham procedure

Sham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy

Trial Locations (10)

10022

Ainsworth Institute of Pain Management, New York

22904

University of Virginia Pain Management Center, Charlottesville

23454

Gershon Pain Specialists, Virginia Beach

27103

Center for Clinical Research, Winston-Salem

30322

Emory, Atlanta

30328

The Physicians Spine and Rehabilitation Specialist of GA, Atlanta

30904

Charlie Norwood VA Medical Center, Augusta

32224

Mayo University Jacksonville, Jacksonville

33136

Univ of Miami Rehabilitation Medicine, Miami

06902

Stamford Hospital, Stamford

All Listed Sponsors
lead

FUSMobile Inc.

INDUSTRY