[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Motiva USA LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100588207","motiva-implants-post-approval-study-100588207",false,"NCT06938399","Motiva Implants® Post-Approval Study","Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures","Motiva PAS","Inclusion Criteria Motiva Implants®:\n\n* Female\n* Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation\n* Patient has adequate tissue available to cover implant(s)\n* Willingness to follow all study requirements\n* Signs an Informed Consent\n* Agrees to have device returned to the Sponsor, if explanted\n* Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised\n\nInclusion Criteria Control group:\n\n* Is 22 years of age or older\n* Female\n* Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)\n* Signs an Informed Consent\n* Willingness to follow all study requirements\n\nExclusion Criteria Motiva Implants®:\n\n* Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2\n* Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)\n* Has an active infection anywhere in their body\n* Is pregnant or nursing, or has had a full-term pregnancy or lactated within 6 months of enrollment\n* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and\u002For significant postoperative complications\n* Has any medical condition such as obesity (BMI \\>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and\u002For significant postoperative complications\n* Has any connective tissue\u002Fautoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others\n* Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure\n* Has been implanted with any non-FDA approved breast implant\n* Has been implanted with any silicone implant other than breast implants\n* HIV positive (based on medical history)\n* Has been diagnosed with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)\n\nExclusion Criteria Control group:\n\n* Has a history of silicone implants (anywhere in the body)\n* Plans to undergo silicone breast implant surgery during the course of the study\n* Has an active infection anywhere in their body\n* Has a history of cancer (except skin cancer)\n* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and\u002For significant postoperative complications\n* Has any medical condition such as obesity (BMI \\>40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and\u002For significant postoperative complications\n* Has any connective tissue\u002Fautoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others",true,"FEMALE","22 Years",{"count":21,"type":22},2400,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.",[28],"Breast Implant",[30,31,32,33,34],"Breast Implants","Breast Surgery","Breast Augmentation","Breast Revision","Silicone Implants","RECRUITING","2026-06-02",{"date":38,"type":39},"2026-06-03","ACTUAL",{"date":41,"type":39},"2025-05-01",{"date":43,"type":22},"2037-07-31",{"name":45,"class":46},"Motiva USA LLC","INDUSTRY",30,""]