NCT06532253尚未招募1 期
Long-term Safety Bucket Trial With NVDX3, an Osteogenic Implant of Human Allogenic Origin.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Long-term safety of the NVDX3 implant
研究概览
简要总结
An study evaluating the long-term safety of all patients previously treated with NVDX3.
详细描述
An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient being implanted with NVDX
- •Previously participated to one of the NVDX3 core clinical trials.
- •Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
- •Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.
排除标准
- •No exclusion criteria are applicable.
研究组 & 干预措施
NVDX3 implant
Experimental
NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space.
干预措施: NVDX3 (Drug)
结局指标
主要结局
Long-term safety of the NVDX3 implant
时间窗: Between screening (V0) and 120 months post-core study (V10)
Description of all SAEs, NVDX3 related AEs and AE of special interest
次要结局
未报告次要终点
研究者
研究点 (1)
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