Clinical Trial

TOUCH® CMC 1 New Enrollment US Study

Study acronym: PAS002
Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-05
notable Trial sites expanded: 0 -> 4 locations 2026-06-05
Trial Details
NCT Number NCT07405983
Lead Sponsor Keri Medical SA
Collaborators: MCRA (an IQVIA business)
Conditions Osteoarthritis Thumb, Thumb Carpometacarpal Joint Osteoarthritis
Enrollment 163 participants
Start Date 2026-03-04
Primary Completion 2029-11 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-04