Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery

3-D Matrix

Status: Unknown

Conditions: Liver Resection

Treatments: Device: PuraStat®

Study type: Observational

Funder types: Industry

Identifiers

NCT03600168

PuraStat-001-LIVER

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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.

Main 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