Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-28 @ 8:02 AM
Study NCT ID:
NCT01706861
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2012-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-24', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of device related adverse events', 'timeFrame': 'Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12', 'description': 'Device safety is defined as the incidence of device related adverse events.'}, {'measure': 'Recurrence of keloid post scar excision', 'timeFrame': 'Assessed at 1, 3, 6, 9 and 12 months', 'description': 'Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume \\>0.3cc'}], 'secondaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': 'Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12'}, {'measure': 'Subject Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12'}, {'measure': 'Device Performance Evaluation', 'timeFrame': 'Assessed at Day 1', 'description': 'Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Earlobe Keloids']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients electing to undergo keloid excision procedure\n* Patients able and willing to give written informed consent\n\nExclusion Criteria:\n\n* Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.'}, 'identificationModule': {'nctId': 'NCT01706861', 'acronym': 'EURO KLEAR', 'briefTitle': 'A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision', 'organization': {'class': 'INDUSTRY', 'fullName': 'Halscion, Inc.'}, 'officialTitle': 'A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR', 'orgStudyIdInfo': {'id': 'HAL-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Celotres', 'description': 'Celotres following surgical removal of earlobe keloid.', 'interventionNames': ['Device: Celotres']}], 'interventions': [{'name': 'Celotres', 'type': 'DEVICE', 'description': 'Celotres following surgical removal of earlobe keloid.', 'armGroupLabels': ['Celotres']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Katowice', 'country': 'Poland', 'facility': 'Angelius Szpital Proviat', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Oddzial Leczenia Oparzen Chirugil Plastysznej', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Nassau', 'country': 'The Bahamas', 'facility': 'University of the West Indies', 'geoPoint': {'lat': 25.05823, 'lon': -77.34306}}, {'zip': 'B15 3SJ', 'city': 'Edgbaston', 'state': 'Birmingham', 'country': 'United Kingdom', 'facility': 'The Westbourne Centre', 'geoPoint': {'lat': 52.4623, 'lon': -1.92115}}], 'overallOfficials': [{'name': 'Sam Bella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Westbourne Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halscion, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}