NCT07081815

JOCOAT Safety and Tolerability Clinical Trial GLAD-04

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: ARC Medical Inc. · Industry
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Adhesions

Interventions

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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-07-23
• Last updated: 2025-09-02