NCT07208448招募中不适用
A Multi-Center, Prospective, First-In-Human Study to Evaluate the Initial Safety and Effectiveness of a Degradable Shoulder Spacer in Patients With Symptomatic Massive Rotator Cuff Tears
Voll Medical Technologies Ltd.4 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2025年12月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Device-related Serious Adverse Events
研究概览
简要总结
The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Full thickness MRCT.
- •Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits.
排除标准
- •Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- •Concurrent participation in any other investigational clinical study.
研究组 & 干预措施
Voll Degradable Shoulder Spacer
Experimental
干预措施: Voll Degradable Shoulder Spacer (Device)
结局指标
主要结局
Device-related Serious Adverse Events
时间窗: Up to 12 months post-implantationץ
Incidence of device-related serious adverse events (DRSAEs) related to the spacer.
次要结局
未报告次要终点
研究者
研究点 (4)
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