Liver Resection
Conditions
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.
Interventions
DEVICEPuraStat®
Synthetic haemostatic material
Sponsors
3-D Matrix Europe SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time-To-Haemostasis | Intraoperatively | Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds) |
Countries
United Kingdom
Outcome results
None listed