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Carpal Arch Space Augmentation (CASA) Clinical Trial
Sponsor: University of Arizona
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
Conditions
Interventions
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.
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