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JOCOAT Safety and Tolerability Clinical Trial GLAD-04

NCT07081815 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-02

No results posted yet for this study

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

DEVICE

JOCOAT(TM) APN-3003

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

Sponsors & Collaborators

  • ARC Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-08-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081815 on ClinicalTrials.gov