PerClot Compared to Usual Care in Gynaecology Procedures

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.

Inclusion criteria

• 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

Exclusion criteria

• • 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