New gel could stop knee surgery scarring in young athletes

NCT ID NCT07081815

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests a liquid gel called JOCOAT APN-3003 that is applied during knee ACL reconstruction surgery to prevent internal scar tissue (adhesions). It involves 24 athletes aged 15 to 25. The gel is placed at the end of surgery, and researchers will check if it improves safety and recovery compared to past patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JOCOAT(TM) APN-3003 liquid adhesion barrier device
What this could lead to
If it works, this could reduce painful scar tissue after knee surgery, helping patients recover better range of motion and return to activity sooner.
What could go wrong
This is a very small early trial with only 24 people, comparing results to past patients rather than a control group. The device may not work better than standard care, and there is a risk of side effects like infection or allergic reaction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Pre-operative Inclusion Criteria: * 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: 1. 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); 2. have a pivot shift of grade 2 or greater; 3. 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 Pre-operative Exclusion Criteria: * 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 * Any general medical or surgical condition that would preclude a standard knee ACLR * Inflammatory arthropathy * Breast feeding * Have a medical condition that, in the opinion of the investigator would interfere with the evaluation of the safety or efficacy of the investigational product * Have received any investigational products that, in the opinion of the investigator, would interfere with the evaluation of the safety or efficacy of the investigational product * Have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, hematological or coagulation disorders * Family history of blood or coagulation disorders * History of heparin-induced thrombocytopenia (HIT) or known sensitivity to heparin-like products Intra-operative Inclusion Criteria: \- Patient undergoes primary anatomic anterior cruciate ligament reconstruction surgery with quadriceps tendon (QT) graft Intra-operative Exclusion Criteria: * Pre-existing arthrofibrosis in the knee * Partial ACL rupture (defined as one bundle ACL tear requiring reconstruction/ augmentation of the torn bundle with no surgery required for the intact bundle) where ACLR is not performed * Multiple ligament injury (two or more ligaments requiring surgery) * Symptomatic articular cartilage defect requiring treatment other than debridement * Articular cartilage lesion that requires any other surgical treatment apart from debridement * Under anesthetic, this patient has a symmetrical or grade 1 pivot shift AND has a Beighton score \<4 AND \<10 degrees hyperextension

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Conditions

The condition(s) this trial relates to.

Tissue Adhesions

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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