NCT07756489尚未招募不适用
SECURE Post-Market Study (PMS): Atraumatic Sutureless Nerve Repair - Evaluation of COAPTIUM CONNECT in a REal-World Clinical Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Tissium
- 入组人数
- 65
- 主要终点
- Sensory Recovery at 6-Months
研究概览
简要总结
The purpose of this post-market study is to generate post-market, real- world evidence on the safety and performance of COAPTIUM® CONNECT with TISSIUM® LIGHT for the atraumatic sutureless repair of acute digital (sensory) injuries of the hand in adults through prospective data collection, to confirm safety and performance of the device.
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
- •Subjects aged 18 years or older at the time of signing the informed consent form.
- •Subjects undergoing surgical repair of an acute peripheral nerve injury as follows:
- •Digital sensory nerve with associated tendon injury, OR
- •Digital sensory nerve without tendon injury.
- •Nerve must be completely transected and appropriate for primary repair.
- •Nerve ends can be reapproximated without excessive tension and without the need for nerve grafting.
- •Wound can be adequately cleaned and has sufficient healthy soft tissue to allow primary closure without adjunctive soft tissue procedures.
- •Nerve injury is deemed by the surgeon to be suitable for repair using COAPTIUM® CONNECT.
- •Subject is willing and able to provide written informed consent prior to any study specific procedures.
- •Subject is willing and able to complete all required visits and procedures at baseline, 1 month, 3 months, 6 months, and 12 months.
排除标准
- •Known or suspected hypersensitivity to any constituents of the product, including the polymer (Aminated polyglycerol sebacate acrylate) or the additive FD&C Blue No. 1 Dye (brilliant blue FCF);
- •Known diagnosis of peripheral neuropathy;
- •Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;
- •Subject's traumatic lesion is older than 14 days at the time of surgery;
- •Use of photosensitizing medications at the time of informed consent.
- •Concomitant neuromodulator medication;
- •Life expectancy less than 1 year;
- •History of neuropathic pain in the affected extremity;
- •History of injury to the nerve being studied;
- •Missing contralateral digit or history of injury to the contralateral digit (comparison/control area);
- •Unwillingness/inability to follow postoperative instructions/follow-up visits;
- •Concomitant intake of systemic immunosuppressive medications, steroids (>20mg of prednisone /day or equivalent) and chemotherapy;
- •Prior radiation therapy to the surgical site;
- •Pregnancy detected by a positive pregnancy test or planned pregnancy during the study period or breast-feeding women;
- •History of chronic ischemic disease involving the affected limb;
- •Diagnosis of type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (at the discretion of the investigator);
- •Subject is currently participating in a study involving an investigational device/drug that has not reached its primary endpoints or would interfere with the study endpoints.
- •Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
- •Previous injury, surgery, pathology involving the same nerve or extremity;
- •Active infection at the surgical site;
- •In the opinion of the Investigator, the subject is not a suitable candidate for the clinical investigation.
研究组 & 干预措施
COAPTIUM® CONNECT
Experimental
Nerve Coaptation Device
干预措施: COAPTIUM® CONNECT (Device)
结局指标
主要结局
Sensory Recovery at 6-Months
时间窗: 6-Months
Rate of higher threshold meaningful recovery (HTMR) at 6 months post-surgery
次要结局
- Sensory Recovery at 12-Months(12-Months)
研究者
相似试验
尚未招募
不适用
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in AdultsHearing LossNCT07338864Cochlear66
招募中
不适用
First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic AneurysmsNCT07330752Angiolutions GmbH12
招募中
Unknown
A Prospective Multicentre Study to Assess the Safety and Performance of the Myval Inception Heart Valve System in Patients with Severe Aortic Valve Narrowing (Stenosis)CTRI/2025/08/092397Meril Diagnostics Private Limited200
进行中（未招募）
不适用
Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye DropsDry Eye DiseaseNCT07540884Alcon Research120
招募中
Unknown
clinical study of two phakic implantable lenses to compare outcomes in patients with moderate to high myopia.CTRI/2025/03/081922Biotech Vision Care Pvt Ltd130