Sonex Health said that it has wrapped up enrollment of patients in the TUTOR trial for the comparison of ultrasound guided carpal tunnel release (CTR) with traditional surgical mini-open CTR release (TUTOR).

The TUTOR trial is the first of its kind multicenter randomized controlled study in the US to compare the effectiveness and safety of conventional miniature-open CTR (mOCTR) when compared to CTR with the US Food and Drug Administration (FDA) approved UltraGuideCTR using ultrasound guide in real-time.

Sonex Health said that the TUTOR trial includes 122 participants who were randomly allocated to undergo one of the two CTR procedures in a dozen clinical investigational locations.

Bob Paulson — Sonex Health CEO said: “We are very grateful to all of the patients who chose to participate in the TUTOR trial, and to the investigators and their staff who committed their time and expertise to advance patient care for the treatment of carpal tunnel syndrome.

“Completing enrollment in this trial is a major milestone, and we thank the investigators and their teams for fully enrolling the TUTOR trial in just 82 days.”

In the course of the study, the patients will be monitored for 12 months after the procedure to collect data on the effectiveness of the treatment, the speed of recovery, return to activity returning to work, and other variables.

UltraGuideCTR is a one-time use, hand-held device that received FDA approval in the year 2019 to treat carpal tunnel syndrome.

  Bob Paulson, carpal tunnel syndrome, Sonex Health, UltraGuideCTR, USA