Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT03600168
Status:
UNKNOWN
Last Update Posted:
2019-09-09
First Post:
2018-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Time-To-Haemostasis', 'timeFrame': 'Intraoperatively', 'description': 'Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Resection']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been previously treated with PuraStat®', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Male or female patient ≥ 18 years old\n* Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent\n* Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent\n* 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.\n\nMain Exclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®\n* Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding\n* Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints'}, 'identificationModule': {'nctId': 'NCT03600168', 'briefTitle': 'Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': '3-D Matrix Europe SAS'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PuraStat-001-LIVER'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PuraStat®', 'type': 'DEVICE', 'description': 'Synthetic haemostatic material'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St James' University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3-D Matrix Europe SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}