[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-implant-shell-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-implant-shell-defect":25},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100655296","prospective-longitudinal-cohort-study-of-implant-age-pocket-plane-incision-surface-texture-and-volume-as-predictors-of-breast-implant-shell-fissure-100655296",false,"NCT07810257","Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure","Inclusion Criteria:\n\n* Female sex and age 18 years or older.\n* Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume.\n* No fissure or rupture identified by the baseline imaging algorithm.\n* Ability to undergo annual ultrasound and confirmatory MRI when indicated.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Confirmed fissure or rupture at cohort entry.\n* Reconstructive breast implantation or tissue expander.\n* Immediate planned implant removal or exchange.\n* Missing core implant characteristics.\n* MRI contraindication when MRI is required to adjudicate a suspected event.\n* Recalled\u002FPIP implant if excluded by the final analytic plan.","ALL","18 Years",{"count":18,"type":19},3000,"ESTIMATED","10 Years","OBSERVATIONAL","This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.",[24,25],"Breast Implant Complication","Breast Implant Shell Defect",[27,28,29,30,31,32],"Breast Implant Fissure","Shell Integrity","Implant Age","Pocket Plane","Incision","Volume","RECRUITING","2026-09-02",{"date":36,"type":37},"2026-09-09","ACTUAL",{"date":39,"type":37},"2014-01-12",{"date":41,"type":19},"2026-12-15",{"name":43,"class":44},"Research Inc","INDUSTRY"]