Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 7:58 AM
Study NCT ID:
NCT00775892
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'lastUpdateSubmitDate': '2011-08-07', 'studyFirstSubmitDate': '2008-10-16', 'studyFirstSubmitQcDate': '2008-10-16', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Adverse Events', 'timeFrame': '12 months'}, {'measure': 'KT-1000 Arthrometer Knee Laxity', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Knee Surveys', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ACL', 'Ligament'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Complete rupture of the ACL\n* Passive flexion \\>= 120° and passive extension = contralateral knee\n* MCL grade 2 or less\n* Pre-injury Tegner score \\>= 4\n* Informed Consent\n\nMajor Exclusion Criteria:\n\n* Prior ACL reconstruction.\n* Severe pain, swelling, or redness\n* Complete PCL tear\n* Complex menisci tears\n* Contralateral knee ligament injury\n* OA \\> Grade II'}, 'identificationModule': {'nctId': 'NCT00775892', 'briefTitle': 'SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Serica Technologies, Inc.'}, 'officialTitle': 'A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair', 'orgStudyIdInfo': {'id': 'CLN-ACL1B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SeriACL Device ACL Reconstruction', 'type': 'DEVICE', 'description': 'Long-term Bioresorbable ACL Scaffold'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salzburg', 'country': 'Austria', 'facility': 'Dr. Pierer Sanatorium', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Altentreptow', 'country': 'Germany', 'facility': 'Dietrich-Bonhöffer-Klinik', 'geoPoint': {'lat': 53.69269, 'lon': 13.25605}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'ATOS Clinic', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Hans Paessler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ATOS Clinic, Heidelberg'}, {'name': 'Johan Bellemans, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven, Belgium'}, {'name': 'Holger Schmitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}, {'name': 'Gerhard Oberthaler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Pierer Sanatorium, Salzburg, Austria'}, {'name': 'Uwe Pietzner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dietrich-Bonhöffer-Klinik, Altentreptow, Germany'}, {'name': 'Michael Jagodzsinki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serica Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rebecca L Horan, PhD', 'oldOrganization': 'Serica Technologies, Inc.'}}}}