[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"3d-printed-biodegradable-biological-mesh\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:3d-printed-biodegradable-biological-mesh":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100621026","study-on-the-cosmetic-outcome-and-safety-evaluation-of-3d-printed-biodegradable-biological-mesh-for-one-stage-breast-reconstruction-after-radical-mastectomy-100621026",false,"NCT07365267","Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy","Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study","Inclusion Criteria:\n\n* Female breast cancer patients aged 18 to 70 years.\n* Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO\u002FNCCN guidelines.\n* Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.\n* ECOG performance status of 0-1.\n* Voluntary participation in the study and signing of the written informed consent form.\n\nExclusion Criteria:\n\n* Age \\>70 years.\n* Metastatic breast cancer (Stage IV) at initial diagnosis.\n* Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.\n* Tumor involvement of the nipple-areolar complex.\n* Breast cancer during pregnancy.\n* History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer.\n* Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery.\n* Patients deemed unsuitable for participation by the investigator.","FEMALE","18 Years","70 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.",[27,28,29],"Breast Cancer","Breast Reconstruction After Mastectomy","3D-Printed Biodegradable Biological Mesh",[29,31],"breast reconstruction","RECRUITING","2026-01-15",{"date":35,"type":36},"2026-01-26","ACTUAL",{"date":33,"type":21},{"date":39,"type":21},"2028-12-01",{"name":41,"class":42},"Xijing Hospital","OTHER"]