Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Panama
ConditionKnee Cartilage Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-60
SponsorNanochon, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 and/or Spanish
Participant must voluntarily sign the REB approved informed consent form (ICF)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Nanochon Chondrograft
DeviceMini arthrotomy or arthroscopic surgical implantation of Nanochon Chondrograft
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Nanochon ChondrograftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serious Adverse Device Effects
Absence of Serious Adverse Device Event Effects (SADEs) through Month 12
Time frame
Month 12Sponsors and contacts
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Source ClinicalTrials.gov