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

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Resection
• Intervention / Treatment: Device: PuraStat®

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • St James' University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously treated with PuraStat®

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time-To-Haemostasis	Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)	Intraoperatively

Collaborators and Investigators

• Sponsor: 3-D Matrix Europe SAS

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): September 4, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: PuraStat-001-LIVER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No