A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- achievement of haemostasis (yes/no).
研究概览
简要总结
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.
详细描述
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care.
All subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. Subjects will be randomized to receive PerClot or usual care.
This research will utilize a multi-center, prospective, randomized controlled study. The study will be conducted in2 study sites in Europe. An assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. The enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. Subjects will be randomized on a 1:1 basis to receive either PerClot or usual care. Data collected from both arms will be compared.
Usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age
- •Subject is undergoing gynecological procedure
- •Subject is willing and able to comply with the protocol and follow up period
- •Subject is willing and able to give written informed consent
排除标准
- •• Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks)
- •Subject is pregnant or actively breastfeeding
- •Subject has a ruptured ectopic pregnancy
- •Subject has a medical history of abnormal coagulopathy or bleeding
- •Subject has a sensitivity to starch or starch derived materials
- •Subject has active or potential infection at the surgical site
- •Subject is currently enrolled in another study
研究组 & 干预措施
PerClot
PerClot® Polysaccharide Hemostatic System (PerClot) is a medical device composed of absorbable polysaccharide particles (AMPs) and delivery applicators. Investigators will have the option to choose 3g or 5g dependent on the requirements of the patient
干预措施: PerClot (Device)
Usual Care
Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm
干预措施: Floseal, Surgicel, Surgiflo, Arista (Device)
Usual Care
Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm
干预措施: Electrocautery/Diatermy (Procedure)
结局指标
主要结局
achievement of haemostasis (yes/no).
时间窗: measured up to 10 minutes after application
visual observation of cessation of bleeding
次要结局
- Absence of re-intervention for post-operative bleeding(within 30 days of initial surgery)