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NOT YET RECRUITING
NCT07081815
NA

JOCOAT Safety and Tolerability Clinical Trial GLAD-04

Sponsor: ARC Medical Inc.

View on ClinicalTrials.gov

Summary

This study will assess the safety and efficacy of a new liquid anti-adhesion device, JOCOAT(TM) APN-3003 in patients undergoing knee anterior cruciate ligament reconstruction (ACLR) surgery. This is a single-center, prospective study. Safety and clinical outcomes will be compared with historical controls from enrolled study site patients from NCT03935750 (STABILITY 2) which has evaluated outcomes following ACL rupture in young athletes. A maximum of 24 patients aged 15-25 years undergoing primary anatomic ACLR with quadriceps tendon (QT) graft following a standardized surgical treatment algorithm will be enrolled. All patients will receive JOCOAT(TM) APN-3003 at the end of their surgery.

Official title: A Single Center Clinical Trial Investigating the Safety and Efficacy of JOCOAT(TM) APN-3003 Liquid Adhesion Barrier Device for Knee Anterior Cruciate Ligament Reconstruction Surgery

Key Details

Gender

All

Age Range

15 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-09

Completion Date

2026-12

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

DEVICE

JOCOAT(TM) APN-3003

10 mL of JOCOAT(TM) APN-3003 is applied at the end of surgery