NCT07249489Not yet recruitingNot Applicable
A First in Human (FIH) Early Feasibility Study (EFS) to Evaluate the Safety and Performance of the Nanochon Chondrograft™ Implant for Re-surfacing of Cartilage Lesions
Nanochon, Inc.2 sites in 1 country10 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Serious Adverse Device Event Effects
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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)
Exclusion Criteria
- •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 the opinion of the investigator at the time of enrollment
- •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 implants that would contraindicate undergoing an MRI
- •Known allergy or hypersensitivity to any investigational device materials.
Arms & Interventions
Nanochon Chondrograft
Experimental
Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft
Intervention: Nanochon Chondrograft (Device)
Outcomes
Primary Outcomes
Serious Adverse Device Event Effects
Time Frame: Month 12
Absence of Serious Adverse Device Event Effects (SADEs) through Month 12
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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