Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT03770195
Status:
WITHDRAWN
Last Update Posted:
2018-12-14
First Post:
2018-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
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}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of Hemostasis at the Target Bleeding Site', 'timeFrame': 'Intraoperatively, expected within 3-10 minutes of application', 'description': 'The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Serious Adverse Device Effects (SADEs)', 'timeFrame': 'Through study completion, on average 14 days post-surgery', 'description': 'The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified'}, {'measure': 'Incidence of Unanticipated Serious Adverse Device Effects (UADEs)', 'timeFrame': 'Through study completion, on average 14 days post-surgery', 'description': 'The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hemostatics', 'Coagulants'], 'conditions': ['Abdominoplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.', 'detailedDescription': 'A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.\n\nEnrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 6 months from the time of first subject enrollment to completion of the last subject follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing elective full abdominoplasty procedures without concomitant liposuction that meet all eligibility criteria.', 'eligibilityCriteria': 'Preoperative Inclusion Criteria:\n\n* Patient is undergoing a primary full abdominoplasty procedure without concomitant liposuction; and\n* Patient is willing and able to give written informed consent for registry participation\n\nPreoperative Exclusion Criteria:\n\n* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and\n* Patient has religious or other objections to porcine, bovine, or human components\n\nIntraoperative Inclusion Criteria\n\n* Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and\n* The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indications for Use'}, 'identificationModule': {'nctId': 'NCT03770195', 'briefTitle': 'Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': "Biom'Up France SAS"}, 'officialTitle': 'Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty', 'orgStudyIdInfo': {'id': 'ETC 2018-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abdominoplasty Patients', 'description': 'Patients undergoing full abdominoplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical', 'interventionNames': ['Device: HEMOBLAST Bellows']}], 'interventions': [{'name': 'HEMOBLAST Bellows', 'type': 'DEVICE', 'description': 'The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.', 'armGroupLabels': ['Abdominoplasty Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28078', 'city': 'Huntsville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hunstad Kortesis Bharti Cosmetic Surgery', 'geoPoint': {'lat': 36.08236, 'lon': -80.5295}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Biom'Up France SAS", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}