NCT07249489尚未招募不适用
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.4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年10月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Serious Adverse Device Event Effects
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Nanochon Chondrograft
Experimental
Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft
干预措施: Nanochon Chondrograft (Device)
结局指标
主要结局
Serious Adverse Device Event Effects
时间窗: Month 12
Absence of Serious Adverse Device Event Effects (SADEs) through Month 12
次要结局
未报告次要终点
研究者
研究点 (4)
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