Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Septodont
- 入组人数
- 125
- 试验地点
- 18
- 主要终点
- Hemostatic Performance at 5 minutes
研究概览
简要总结
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery.
Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month.
Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring oral surgery
- •Patient with a bleeding requiring the use of an adjuvant hemostatic
- •Patient implanted with HEMOCOLLAGENE® in dental surgery.
- •Patient who signed his informed consent form
排除标准
- •Inform Consent not signed
- •Patients with acute oral infection.
- •Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem)
- •Pregnant and / or breastfeeding patients.
- •Patient with hypersensitivity or allergy to bovine collagen
结局指标
主要结局
Hemostatic Performance at 5 minutes
时间窗: 5 minutes after treatment onset
Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.
次要结局
- Wound Healing(At 30 days)
- Rate of persistant bleeding(5 minutes after treatment onset)
- Ease of the use of Hemocollagene by the Dentist(At day 0, after using the treatment)
- Rate of device related adverse events(From treatment onset to 30 days)
- Rate of overall adverse events(From treatment onset to 30 days)
- Rate of hemostatic time at 10 minutes in case persistant bleeding(10 minutes after treatment onset)