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New treatment option for Knee Cartilage Lesions
Official title Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada
ClinicalTrials.gov ID: NCT07249489
What this study is testing
- What it's testing
- The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee. This study will include males and females between the ages of 22 and 60.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 60
You may be able to join if
- Male or female ≥22 years and ≤ 60 years of age
- MRI knee evaluation completed within 6 months prior to enrollment
- Participant must be able to read and speak English
- Participant must voluntarily sign the REB approved informed consent form (ICF)
You likely can't join if
- Any known systemic cartilage and/or bone disorder, such as, but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
- Requires bilateral knee surgery
- Pregnancy, planning to become pregnant or breast feeding
- Any significant illness (metastasis cancer of any type) that decreases the probability of the participant's survival to 12 months
- Known insulin dependent diabetes mellitus
- Steroid treatment (oral or IV) within the past 6 months
See the full eligibility criteria
- Male or female ≥22 years and ≤ 60 years of age
- MRI knee evaluation completed within 6 months prior to enrollment
- Participant must be able to read and speak English
- Participant must voluntarily sign the REB approved informed consent form (ICF)
- Any known systemic cartilage and/or bone disorder, such as, but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
- Requires bilateral knee surgery
- Pregnancy, planning to become pregnant or breast feeding
- Any significant illness (metastasis cancer of any type) that decreases the probability of the participant's survival to 12 months
- Known insulin dependent diabetes mellitus
- Steroid treatment (oral or IV) within the past 6 months
- Participant is:
- receiving workman's compensation
- receiving prescription narcotic medication
- active with litigation relating to musculoskeletal injuries or disorders
- a prisoner or pending incarceration
- Comorbidities that could impact study participation or results (e.g., autoimmune disorder, HIV, neuropathic pain or fibromyalgia, restless leg syndrome, active infection, or pain requiring chronic pain management), in...
- Significant psychiatric disorders (e.g., major depression, anxiety disorders, bipolar disorder, and schizophrenia)
- Substance and/or alcohol dependence and/or abuse based on clinical history, physical exam and participant presentation
- Current participation in another drug or device study that, in the opinion of the investigator at the time of enrollment, would interfere with participation in this study
- Participant has claustrophobia or implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated...
- Known allergy or hypersensitivity to any investigational device materials.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.