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

NCT03600168 | Unknown

• 1 other identifier: PuraStat-001-LIVER
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Resection

Outcome Measures

Primary Outcomes (1)

• Total Time-To-Haemostasis

  Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)

  Intraoperatively

Interventions

PuraStat® DEVICE

Synthetic haemostatic material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously treated with PuraStat®

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 3-D Matrix Europe SAS: lead

Study Sites (1)

St James' University Hospital

Leeds, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: August 2, 2018
• Primary Completion: September 4, 2019
• Study Completion: February 1, 2020
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)