PuraStat®; Post Market Performance during Liver Surgery
Research type
Research Study
Full title
A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of PuraStat® Absorbable Haemostatic Material for the Management of Bleeding After Open Liver Resection
IRAS ID
244488
Contact name
Caroline Leblanc
Contact email
Sponsor organisation
3-D Matrix Europe SAS
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The study is a multi-centre, post-market clinical study to confirm the safety and performance of PuraStat®, an absorbable haemostatic material used for the management of bleeding during Liver surgery.
The study will primarily assess "time-to-haemostasis" after the application of PuraStat® in patients undergoing open Liver resection. In addition, the study will continue to assess the safety profile of this already CE-marked haemostatic material.
Up to 80 patients, clinically indicated for Liver resection will be invited to participate in the study.
It is anticipated that up to 10 hospitals across Europe, including NHS Hospitals in the UK, will participate and that patient recruitment will be completed within 9 months.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0308
Date of REC Opinion
18 Jun 2018
REC opinion
Further Information Favourable Opinion