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

Liver Resection Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03600168
• Other study ID #: PuraStat-001-LIVER
• Status: Active, not recruiting
• Start date: August 2, 2018
• Est. completion date: February 2020

Study information

• Verified date: September 2019
• Source: 3-D Matrix Europe SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: September 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Liver Resection

Intervention

Device:
• PuraStat®
Synthetic haemostatic material

Locations

Country	Name	City	State
United Kingdom	St James' University Hospital	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
3-D Matrix Europe SAS

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Time-To-Haemostasis	Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)	Intraoperatively