Status unknownNCT03600168Updated Sep 9, 2019

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

An observational study in Liver Resection, sponsored by 3-D Matrix Europe SAS. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-09.

Sponsored by 3-D Matrix Europe SAS · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 80
Ages: 18 Years and older
Sex: All

Study 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 studied

Liver Resection

In context

Lead sponsor

3-D Matrix Europe SAS is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients who have been previously treated with PuraStat®

Eligibility 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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 80 participants (actual)
Patient registry: No

Interventions

DevicePuraStat®
Synthetic haemostatic material

What researchers measure

Primary outcomes

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

Study locations

1 site

St James' University Hospital
Leeds, United Kingdom

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03600168
Lead sponsor: 3-D Matrix Europe SAS
Responsible party: Sponsor
First posted: Jul 26, 2018
Start date: Aug 2, 2018
Primary completion: Sep 4, 2019
Completion: Feb 2020 (estimated)
Last update: Sep 9, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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