Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Patients Who Undergo Revision in Spine Surgery After at Least One Year (CADISS1701)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Ability of the CADISS® System to dissect fibrosis without cutting
研究概览
简要总结
The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. It is based on the property of the drug mesna (Sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. Revision spine surgery is more difficult than primary surgery because of the development of fibrosis and scar tissues since the first operation. Fibrosis may develop in the spinal canal and will adhere strongly to the dura mater and to the nerve roots. This study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of CADISS medical devices to facilitate dissection of epidural fibrosis in patients who undergo a revision in spine surgery after at least one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •≥ 18 years old, weight > 30 Kg
- •Eligible for Spine revision surgery, at least one year after primary surgery
- •Agree to participate and sign the informed consent
- •The age and weight of patient are defined according to the instruction for use of the CADISS System currently on the EU market.
排除标准
- •< 18 years old
- •Weight ≤ 30 kg
- •Primary surgery
- •Known hypersensibility to mesna
- •Patient is pregnant, breastfeeding or has wish of pregnancy during the study.
- •Unable to sign the informed consent
- •Participation in any study involving an investigational drug or device within the past 3 Months.
- •Individuals under tutorship or trusteeship.
结局指标
主要结局
Ability of the CADISS® System to dissect fibrosis without cutting
时间窗: Surgery
Percentage of successful dissection
次要结局
- The facilitation of fibrosis detachment with the CADISS System(Surgery)
- The capability of the CADISS system to highlights cleavage plane(Surgery)
- The reduction of bleeding with the use of the CADISS System(Surgery)
- The speed of action of the mesna solution after local instillation(Surgery)
- The ease of use of the CADISS System(Surgery)
- The easy of control of the topical application with the CADISS System(Surgery)
- Adverse events(surgery, at hospital discharge minimum 1 day after surgery, 6 weeks)
- Global satisfaction score when using the(Surgery)