NCT02835391

PerClot Compared to Usual Care in Gynaecology Procedures

A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: CryoLife Europa · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endometriosis
• Ovarian Cyst
• Menorrhagia
• Cancer
• Uterine Fibroids

Interventions

Type	Name	Description
DEVICE	PerClot	Haemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical.
DEVICE	Floseal, Surgicel, Surgiflo, Arista	Haemostatic device for the control of bleeding
PROCEDURE	Electrocautery/Diatermy	Procedure for the control of bleeding

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2016-07-18
• Last updated: 2017-09-01

Locations

1 site across 1 country: Spain