Cancer Clinical Trial
Official title:
A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures
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.
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.
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