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Набира участници Не е приложимо NCT07249489

Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada

Не е приложима фаза (напр. обсервационно)
Заболявания: Knee Cartilage Lesions

Спонсор: Nanochon, Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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: 1. receiving workman's compensation 2. receiving prescription narcotic medication 3. active with litigation relating to musculoskeletal injuries or disorders 4. 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.
Интервенции
Nanochon Chondrograft
DEVICE
Места на провеждане 2
Канада (2)
Fraser Orthopaedic Institute
New Westminster , British Columbia
University of British Columbia
Vancouver , British Columbia
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
22 Years
Максимална възраст
60 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
01.08.2027
Регистрационен номер
NCT07249489
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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