[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"implant-based-breast-reconstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:implant-based-breast-reconstruction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,72,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100514198","blossom-smart-expander-device-for-tissue-expanderimplant-based-breast-reconstruction-100514198",false,"NCT05975372","Blossom® Smart Expander Device for Tissue Expander\u002FImplant-Based Breast Reconstruction","Inclusion Criteria:\n\n* Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander\u002F implant-based breast reconstruction will be approached for potential enrollment in the study.\n\nExclusion Criteria:\n\n* Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.",true,"ALL","18 Years","65 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The conventional breast tissue expander used for breast reconstruction\u002F augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander\u002Fimplant-based breast reconstruction\u002F augmentation compared to standard tissue expansion methods.",[27,28],"Tissue Expansion","Implant Based Breast Reconstruction",[30,31],"Implant based breast reconstruction","Tissue expansion","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2023-11-17",{"date":40,"type":21},"2028-07",{"name":42,"class":43},"Stanford University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100555367","post-market-surveillance-study-to-evaluate-the-quality-of-life-and-the-safety-and-effectiveness-of-the-tigr-matrix-after-reconstructive-breast-surgery-100555367","NCT06511167","Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery","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","TIGR-Matrix","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 \\\u003C 5 years)\n* Medicinal dis-regulated diabetes\n* Inadequate bone marrow function with neutrophil granulocytes\\\u003C1500 and blood plates \\\u003C 100.000\u002Fµl\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.","FEMALE",{"count":55,"type":21},135,"OBSERVATIONAL","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.",[28],[60,61],"TIGR® Matrix","Quality of Life","2026-05-06",{"date":64,"type":36},"2026-05-11",{"date":66,"type":36},"2024-11-08",{"date":68,"type":21},"2029-01",{"name":70,"class":43},"AWOgyn",5,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":44},"100514197","assessment-of-the-interi-manifold-in-implant-based-breast-reconstruction-100514197","NCT05975359","Assessment of the Interi Manifold in Implant-Based Breast Reconstruction","A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction","Inclusion Criteria:\n\n1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.\n2. Indication for bilateral mastectomy\n3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix\n4. Age 18 - 65\n5. Female Sex\n6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).\n\nExclusion Criteria:\n\n1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.\n2. Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.\n3. Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and\u002F or other anticoagulation therapy in the past 60 days.\n4. Are a smoker or use illicit drugs.\n5. Any prior allergic reaction to Teflon.\n6. Are pregnant or nursing.\n7. Are undergoing a delayed reconstruction following mastectomy.\n8. HIV infection, active UTI infection, or other active infection.\n9. Those requiring more than one Manifold for fluid removal per breast will be excluded.",{"count":20,"type":21},[24],"Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.",[83,28],"Mastectomy","2026-04-09",{"date":86,"type":36},"2026-04-13",{"date":88,"type":36},"2023-10-05",{"date":90,"type":21},"2026-09",{"name":42,"class":43},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":53,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":44},"100577358","flexhd-pliable-investigation-in-implant-based-breast-reconstruction-100577358","NCT06797258","FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction","Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction","SHAPE","Inclusion Criteria:\n\n* Females at least 22 years of age\n* Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction\n* Willing to provide Informed Consent\n* Able to return for all required study visits\n* Must read and understand English language\n\nExclusion Criteria:\n\n* Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure\n* Has a residual gross tumor at the intended reconstruction site\n* Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy\n* Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site\n* Completed chemotherapy within 3 weeks prior to surgery\n* Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications\n* Has a Body Mass Index (BMI) \\>35\n* Has used nicotine products within 1 month of screening\n* Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study","22 Years",{"count":102,"type":21},259,[24],"Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique",[28],"2025-03-27",{"date":108,"type":36},"2025-04-02",{"date":110,"type":36},"2025-03-26",{"date":112,"type":21},"2027-08",{"name":114,"class":43},"Musculoskeletal Transplant Foundation"]