JOCOAT Safety and Tolerability Clinical Trial GLAD-04

NCT07081815 | Not Yet Recruiting

• 1 other identifier: ARCMD-GLAD-04
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety of JOCOAT(TM) APN-3003 as measured by number and severity of adverse device effects and serious adverse device effects

  The number of severe and serious adverse events in treated subjects from this study is compared with the number seen in historical controls

  3 months after surgery

Secondary Outcomes (4)

• Exploratory efficacy of JOCOAT(TM) APN-3003 as measured by comparing range of motion (ROM) pre-operatively and post-operatively

  3 months after surgery

• Patient recovery as measured by Patient Reported Outcome Measures (KOOS)

  Up to 12 months after surgery

• Patient recovery as measured by Patient Reported Outcome Measures (PASS)

  Up to 12 months after surgery

• Patient recovery as measured by Patient Reported Outcome Measures (EQ-5D-5L)

  Up to 12 months after surgery

Study Arms (1)

JOCOAT(TM) APN-3003

EXPERIMENTAL

Intra-articular injection

Device: JOCOAT(TM) APN-3003

Interventions

JOCOAT(TM) APN-3003 DEVICE

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

JOCOAT(TM) APN-3003

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Understand and be able to follow the requirements of the protocol including personally signing and dating an REB approved Informed Consent Form prior to undergoing any protocol related procedures
• Subjects aged 15 to 25 years with an ACL-deficient knee undergoing primary ACLR
• Subjects with skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs)
• At least two of the following factors that are associated with a high risk of graft failure:
• participate in a competitive pivoting sport (defined as sports that include cutting and pivoting activities such as basketball, American football, soccer, lacrosse, volleyball, tennis/squash, handball, downhill skiing etc);
• have a pivot shift of grade 2 or greater;
• have generalized ligamentous laxity (Beighton score of \>= 4) and/or genu recurvatum \> 10 degrees
• Biological females have a negative pregnancy test within 4 days of initial surgery
• Is willing, able and likely to fully comply with clinical trial procedures and restrictions including follow-ups

You may not qualify if:

• Simultaneous bilateral ACLR
• Previous ACLR on either knee
• Less than one year from contralateral knee or contralateral/ipsilateral hip/ankle surgery
• Prior arthrotomy in the study knee
• Active infection anywhere or previous infection in the study knee
• History of peri-articular fracture in study knee
• \> 3 degrees of asymmetric varus or valgus
• The patient has debilitating knee pain that would preclude the use of QT tissue as a graft
• The patient has a significant quad tendonitis that would preclude the use of QT tissue as a graft
• Known or suspected allergy to brown seaweed, seaweed-based materials such as fucoidan, food allergies and/or presence of any allergy related dietary restrictions unless deemed by the investigator as "Not Clinically Significant"
• Known or suspected allergy to fucose, galactose, sulfur, sulfate, sulfite, or any sugar-based polymer or polysaccharides containing these
• Known hypersensitivity to sodium lactate or sulfur-containing compounds
• Any other severe allergic conditions or previous reactions (e.g., anaphylactic reactions, angioedema)
• Severe metabolic acidosis or alkalosis
• Have insulin dependent diabetes, severe diabetes and/or poorly controlled diabetes mellitus

Sponsors & Collaborators

• ARC Medical Inc.: lead

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients in this study will receive the investigational treatment. Safety and clinical outcomes from this study will be compared with historical controls from enrolled study site patients from NCT03935750.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08