Liver ResectionNCT03600168
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 of Liver Resection, run by 3-D Matrix Europe SAS at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Resection
- What is being tested?
- PuraStat®
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2018to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been previously treated with PuraStat®
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PuraStat®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraStat®Device
Synthetic haemostatic material
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Time-To-Haemostasis
Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 Aug 2018
- Primary completion4 Sep 2019
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-D Matrix Europe SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600168
- Sponsor's protocol ID
- PuraStat-001-LIVER
- Status last verified
- Sep 2019
- First submitted
- 17 Jul 2018
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03600168
- Acronym / sponsor ID
- PuraStat-001-LIVER
- Conditions
- Liver Resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- 3-D Matrix Europe SASIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been previously treated with PuraStat®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PuraStat®Synthetic haemostatic material | Device | – |
Primary outcome
Total Time-To-Haemostasis
Time frame: Intraoperatively
Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Resection, run by 3-D Matrix Europe SAS at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Time-To-Haemostasis (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.