Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
Study NCT ID:
NCT04471350
Status:
WITHDRAWN
Last Update Posted:
2021-08-30
First Post:
2020-07-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-market Evaluation of HEMOBLAST™ Bellows in Spine 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'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Indication withdrawn', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of Hemostasis', 'timeFrame': 'Intraoperatively, expected within 3-10 minutes of application', 'description': 'The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Serious Adverse Device Effects (SADEs)', 'timeFrame': '4 weeks +/- 2 weeks', 'description': 'The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows'}, {'measure': 'Re-bleeding at Target Bleeding Site', 'timeFrame': 'Intraoperative, prior to surgical closure of the subject', 'description': 'The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows'}, {'measure': 'Re-operation due to bleeding', 'timeFrame': 'Post-operatively, expected within 1-28 days of the surgical procedure', 'description': 'The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemostasis']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery', 'detailedDescription': 'Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing spine surgery that meet all of the inclusion criteria and none of the exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pre-operative Inclusion Criteria:\n\n* Patient is undergoing a non-emergent spine surgery\n* Patient is willing and able to give prior written informed consent for investigation participation;\n* Patient is 18 years of age or older.\n\nIntra-operative Inclusion Criteria\n\n* Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.\n* The TBS(s) has been treated with HEMOBLAST™ Bellows per instructions for use.\n\nExclusion Criteria:\n\n* Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;\n* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;\n* Patient has religious or other objections to porcine, bovine, or human components;\n* Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion\n* Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator'}, 'identificationModule': {'nctId': 'NCT04471350', 'briefTitle': 'Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': "Biom'Up France SAS"}, 'officialTitle': 'Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery', 'orgStudyIdInfo': {'id': 'ETC 2018-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HEMOBLAST™ Bellows', 'type': 'DEVICE', 'description': 'Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in spine surgery.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': "L'Hôpital privé du Confluent", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Pierre-Marie Longis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "L'Hôpital privé du Confluent"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Biom'Up France SAS", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}