[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495834":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":31,"responsibleParty":75,"collaborators":78,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":10,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Indiana University","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"BII Subjects",null,"Subjects with breast implants having BII manifestations.",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-BII Subjects","Subjects with breast implants with no reported BII symptoms.",{"label":16,"type":10,"description":17,"interventionNames":10},"Subjects without Breast Implants","Subjects without breast implants.",[19],{"name":20,"affiliation":5,"role":21},"Mithun Sinha, PhD.","PRINCIPAL_INVESTIGATOR",[23,27],{"name":20,"role":24,"phone":25,"phoneExt":10,"email":26},"CONTACT","3172782713","mitsinha@iu.edu",{"name":28,"role":24,"phone":29,"phoneExt":10,"email":30},"Bryce Hockman","3172782715","bbhockma@iu.edu",[32,49,58],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"IU Health North Hospital","RECRUITING","Carmel","Indiana","46032","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-86.11804,39.97837,{"lat":44,"lon":43},[47],{"name":48,"role":24,"phone":10,"phoneExt":10,"email":10},"Jason VonDerHaar, MD",{"facility":50,"status":34,"city":35,"state":36,"zip":51,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Meridian Plastic Surgeons","46290",{"type":41,"coordinates":53},[43,44],{"lat":44,"lon":43},[56],{"name":57,"role":24,"phone":10,"phoneExt":10,"email":10},"Christine Kelley-Patteson, MD",{"facility":59,"status":34,"city":60,"state":36,"zip":61,"country":38,"countryCode":39,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"IU Health Methodist Hospital","Indianapolis","46202",{"type":41,"coordinates":63},[64,65],-86.15804,39.76838,{"lat":65,"lon":64},[68,71,72],{"name":69,"role":24,"phone":10,"phoneExt":10,"email":70},"Mary Lester","melester@iupui.edu",{"name":28,"role":24,"phone":29,"phoneExt":10,"email":30},{"name":73,"role":74,"phone":10,"phoneExt":10,"email":10},"Aladdin Hassanein, MD","SUB_INVESTIGATOR",{"type":21,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mithun Sinha","Assistant Professor",[79,82],{"name":80,"class":81},"National Institutes of Health (NIH)","NIH",{"name":83,"class":81},"National Institute of Allergy and Infectious Diseases (NIAID)","100495834","molecular-mechanisms-associated-with-breast-implant-complications-100495834",false,"NCT05736354","Molecular Mechanisms Associated With Breast Implant Complications","MMABIC","Inclusion Criteria for breast implant subjects:\n\n* Age greater than or equal to 18 years\n* Undergoing removal of breast implant\n* Willing and able to comply with protocol instructions\n\nInclusion Criteria for subjects undergoing breast surgeries (other than implant removal)\n\n* Age greater than or equal to 18 years\n* Undergoing breast surgery\n* Willing and able to comply with protocol instructions\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)\n* Pregnant females\n* Immunodeficiency (HIV\u002FAIDS, SCID)\n* Currently on immunosuppressive medications\n* Prisoners","FEMALE","18 Years",{"count":94,"type":95},1000,"ESTIMATED","OBSERVATIONAL","Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.",[99,100],"Breast Implant; Complications","Infection or Inflammation","2026-06-09",{"date":103,"type":104},"2026-06-11","ACTUAL",{"date":106,"type":104},"2021-01-03",{"date":108,"type":95},"2028-06-30",{"name":5,"class":6},3]