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RECRUITING
NCT06208709
NA

Carpal Arch Space Augmentation (CASA) Clinical Trial

Sponsor: University of Arizona

View on ClinicalTrials.gov

Summary

This research proposes to evaluate the effectiveness of a novel device designed for the treatment of carpal tunnel syndrome. The device applies a small cyclic force to the wrist. The cycles include a small time period of force is applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep. The efficacy of the treatment is evaluated based on patient reported outcomes. Treatment efficacy will also be evaluated based on comparisons to patient reported outcomes for a SOC treatment.

Official title: Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2024-04-23

Completion Date

2026-07-31

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DEVICE

carpal arch space augmentation (CASA)

A BOA brace with a balloon that is affixed internally. The device applies a small cyclic force of to the wrist. The cycles include a brief period of force applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep.

DEVICE

standard of care (SOC)

A BOA brace that can be adjusted to the arm of the participant.

Locations (1)

University of Arizona

Tucson, Arizona, United States