Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-03 @ 6:55 PM
Study NCT ID:
NCT06511167
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life 12 months after surgery (BREAST-Q)', 'timeFrame': '12 months after surgery', 'description': "Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities"}], 'secondaryOutcomes': [{'measure': 'Quality of Life 6, 24, 36 months after surgery (BREAST-Q)', 'timeFrame': '6, 24, 36 months after surgery', 'description': "Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities"}, {'measure': 'Complication rate', 'timeFrame': 'minimum of 3 years and a maximum of 5 years after surgery', 'description': 'The number and rate of occurrence of major complications, minor complications; Serious Adverse Events (SAEs) and Adverse Events (AEs)'}, {'measure': 'Complication rate of specific complications', 'timeFrame': 'minimum of 3 years and a maximum of 5 years after surgery', 'description': 'Complication rate of:\n\n* Seroma-Volume (Sum of fluid-volume during the drainage-time)\n* Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up\n* Reconstructive failure (defined as unplanned implant loss)'}, {'measure': 'Days with drain(s)', 'timeFrame': 'during hospital stay after surgery', 'description': 'The number of days between placement of drain system and removal of the drain'}, {'measure': 'Days of hospital stay', 'timeFrame': 'surgery to discharge from hospital', 'description': 'The number of days the participant spend in hospital after surgery'}, {'measure': 'Cosmetic outcome', 'timeFrame': '6, 12, 24 ,36 month after surgery', 'description': 'Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician'}, {'measure': 'Rate of unplanned conversion operations', 'timeFrame': 'minimum of 3 years and a maximum of 5 years after surgery', 'description': 'Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TIGR® Matrix', 'Quality of Life'], 'conditions': ['Implant Based Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.', 'detailedDescription': "This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who will undergo breast prepectoral implant-based breast reconstructive surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation\n* The health of women must comply with ECOG performance status 0-2\n* The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment\n* Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation\n* Patient information has been handed out and subject signed informed consent\n* Participant has attained full age of 18 years\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding patients\n* Known intolerance to the material, mesh-implants under investigation\n* Metastatic breast cancer (with a life expectancy \\< 5 years)\n* Medicinal dis-regulated diabetes\n* Inadequate bone marrow function with neutrophil granulocytes\\<1500 and blood plates \\< 100.000/µl\n* Lack or withdrawn of written patients informed consent\n* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol\n* Participant is institutionalized by court or official order (MPDG §27)\n* Participation in another surgical clinical investigation that influence the surgical technique or outcome.'}, 'identificationModule': {'nctId': 'NCT06511167', 'acronym': 'TIGR-Matrix', 'briefTitle': 'Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'AWOgyn'}, 'officialTitle': 'National, Prospective, Multicentre Post Market Surveillance Study on "Patient Reported Outcome" of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR® Matrix', 'orgStudyIdInfo': {'id': 'AWO-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TIGR® Matrix', 'type': 'DEVICE', 'description': 'bioresorbable, synthetic, surgical mesh'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69469', 'city': 'Weinheim', 'state': 'Baden-Wurttemberg', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'GRN-Klinik Weinheim', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'zip': '80337', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Evelyn Klein, Dr. med.', 'role': 'CONTACT', 'email': 'evelyn.klein@tum.de', 'phone': '+49 89 41402433'}, {'name': 'Evelyn Klein, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik und Poliklinik für Frauenheilkunde Technische Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '60431', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Katharina Kelling, Dr. med.', 'role': 'CONTACT', 'email': 'katharina.kelling@agaplesion.de', 'phone': '+49 69 95 33 66 754'}, {'name': 'Katharina Kelling, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Agaplesion Markus Krankenhaus Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '46485', 'city': 'Wesel', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniela Rezek, Dr. med.', 'role': 'CONTACT', 'email': 'daniela.rezek@evkwesel.de', 'phone': '+49 281 106 2324'}, {'name': 'Daniela Rezek, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evangelisches Krankenhaus Wesel', 'geoPoint': {'lat': 51.6669, 'lon': 6.62037}}, {'zip': '06110', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tilmann Lantzsch, Dr. med.', 'role': 'CONTACT', 'email': 't.lantzsch@krankenhaus-halle-saale.de', 'phone': '+49 345 213 4341'}, {'name': 'Tilmann Lantzsch, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'centralContacts': [{'name': 'Marc Thill, Prof.', 'role': 'CONTACT', 'email': 'Marc.Thill@agaplesion.de', 'phone': '+49 69 95 33 22 28'}], 'overallOfficials': [{'name': 'Marc Thill, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'AWOgyn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AWOgyn', 'class': 'OTHER'}, 'collaborators': [{'name': 'Esculape GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}