Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT02881359
Status:
UNKNOWN
Last Update Posted:
2018-04-02
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-29', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post-operative clinical anastomotic leaks at discharge', 'timeFrame': 'discharge from hospital 3-14 days post surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery', 'timeFrame': 'up to 4 weeks post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anastomotic Leakage']}, 'descriptionModule': {'briefSummary': 'This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate', 'detailedDescription': 'The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years of age at screening visit\n2. Written informed consent obtained\n3. Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis\\* created within 15 cm from the anal verge.\n4. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU\n\nExclusion Criteria:\n\n1\\. Subject with American Society of Anesthesiology (ASA) status \\> 3.'}, 'identificationModule': {'nctId': 'NCT02881359', 'briefTitle': 'SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit', 'organization': {'class': 'INDUSTRY', 'fullName': 'LifeBond Ltd.'}, 'officialTitle': 'SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection', 'orgStudyIdInfo': {'id': 'CLP-LS-0146'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LifeSeal® Kit', 'description': 'creation of a coloanal or colorectal anastomosis', 'interventionNames': ['Device: LifeSeal® Kit']}], 'interventions': [{'name': 'LifeSeal® Kit', 'type': 'DEVICE', 'description': 'used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.', 'armGroupLabels': ['LifeSeal® Kit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Algemeen Stedelijk Ziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Antwerpen Campus', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Ieper', 'country': 'Belgium', 'facility': 'Jan Yperman Ziekenhuis', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '2400', 'city': 'Mol', 'country': 'Belgium', 'facility': 'H. Hartziekenhuis', 'geoPoint': {'lat': 51.19188, 'lon': 5.11662}}, {'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Almelo', 'country': 'Netherlands', 'facility': 'ZGT', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LifeBond Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}