Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
Study NCT ID:
NCT06575192
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 783}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1', 'timeFrame': 'Month 18', 'description': 'Number of participants with at least one major complication related to breast reconstruction.'}, {'measure': 'Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2', 'timeFrame': 'Up to Month 18', 'description': 'Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to Approximately 36 Months', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Capsular Contracture per Breast', 'timeFrame': 'Month 36', 'description': 'Number of participants with an occurrence of capsular contracture per breast.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast Reconstruction', 'ADORA', 'ARTIA'], 'conditions': ['Breast Reconstruction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-708', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who will undergo unilateral or bilateral mastectomy upon enrollment.\n* Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.\n\nExclusion Criteria:\n\n* Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.\n* Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.'}, 'identificationModule': {'nctId': 'NCT06575192', 'briefTitle': 'Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy', 'orgStudyIdInfo': {'id': 'M24-708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acellular Dermal Matrix', 'description': 'Breast reconstruction with ARTIA Tissue Matrix.', 'interventionNames': ['Device: ARTIA Reconstructive Tissue Matrix']}, {'type': 'OTHER', 'label': 'Non-Acellular Dermal Matrix (ADM) Control Group', 'description': 'Breast reconstruction without ADM.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'ARTIA Reconstructive Tissue Matrix', 'type': 'DEVICE', 'description': 'Surgical Implant', 'armGroupLabels': ['Acellular Dermal Matrix']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': 'No ADM', 'armGroupLabels': ['Non-Acellular Dermal Matrix (ADM) Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center /ID# 268326', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868-3201', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC Irvine Medical Center /ID# 267428', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford University Medical Center CTRU - 800 Welch Road /ID# 264196', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'South Bay Plastic Surgeons /ID# 264192', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Florida College of Medicine /ID# 267485', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60062-2802', 'city': 'Northbrook', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Endeavor Health /ID# 266302', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Johns Hopkins Hospital /ID# 265917', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine - St. Louis /ID# 264029', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89154', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Nevada - Main Campus /ID# 264017', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School - Newark /ID# 264187', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwell Health Clinical Trials Office /ID# 268076', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10016-6402', 'city': 'New York', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'NYU Langone Medical Center /ID# 265621', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist Medical Center /ID# 264382', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43202', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center /ID# 266253', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Erlanger Health System /ID# 266608', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37614', 'city': 'Johnson City', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'East Tennessee State University /ID# 264321', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center /ID# 264020', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia /ID# 265098', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98660', 'city': 'Vancouver', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'AG Aesthetic Center /ID# 264233', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}