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

3-D Matrix Europe SAS1 site in 1 country80 target enrollmentAugust 2, 2018

ConditionsLiver Resection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Liver Resection
Sponsor: 3-D Matrix Europe SAS
Enrollment: 80
Locations: 1
Primary Endpoint: Total Time-To-Haemostasis
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.

Registry

clinicaltrials.gov

Start Date

August 2, 2018

End Date

February 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

3-D Matrix Europe SAS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patient ≥ 18 years old
•Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent
•Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent
•Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up.

Exclusion Criteria

•Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®
•Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
•Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints