[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Establishment Labs\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100527320","motiva-flora-aesthetic-breast-recon-clinical-study-100527320",false,"NCT06146231","Motiva Flora® Aesthetic Breast Recon® Clinical Study","Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study","Inclusion Criteria:\n\n1. Genetically female, aged 18 years or older.\n2. Subjects who had provided written informed consent form.\n3. The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.\n4. Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.\n5. Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.\n6. Complete radiotherapy and chemotherapy at least one year before surgery.\n7. BMI between 18.5 and 30.0 (average classified weight).\n8. Physical and cognitive capacity to understand and follow the surgeon's recommendations.\n9. To be able and willing to comply with all study requirements, including attending follow-up appointments.\n\n   Only Sub study participants\n10. Provide additional consent to undergo an MRI with contrast.\n\nExclusion Criteria:\n\n1. Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.\n2. Abnormal hematological and biochemical values after chemotherapy.\n3. High surgical risk according to the investigator.\n4. Breast width larger than 18 cm\n5. Tumor residues in or near the area where tissue expansion is performed.\n6. Subjects with metastatic breast cancer\n7. Significant Breast ptosis or poor skin quality\n8. Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing, or mastectomy scar deformity.\n9. Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.\n10. Current or previous infection in the area where the expansion occurs.\n11. Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.\n12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.\n13. History of silicone sensitivity.\n14. Active smokers\n15. Previous attempts of breast reconstruction\n16. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population\n17. Subjects with affiliation to the Sponsor, sites or investigators, including relatives.\n18. Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.\n19. Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study","FEMALE","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"NA","The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.",[26,27,28],"Mammaplasty","Breast Cancer","Poland Syndrome",[30,31,32,33,34],"Reverse expansion","Aesthetic BreastRecon™","Hybrid breast reconstruction","Implant","Autologous tissue","RECRUITING","2025-11-21",{"date":38,"type":39},"2025-11-26","ACTUAL",{"date":41,"type":39},"2023-08-18",{"date":43,"type":20},"2027-04",{"name":45,"class":46},"Establishment Labs","INDUSTRY",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100603322","adaptive-study-to-assess-the-safety-and-functioning-of-motiva-devices-on-minimally-invasive-gluteal-augmentation-100603322","NCT07135011","Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation","Adaptive Study to Assess the Initial Safety and Functioning of the Minimally Invasive Gluteal Augmentation Procedure and Its Devices in Participants Undergoing Primary Gluteal Enhancement","GEM","Inclusion Criteria:\n\n* Cisgender women, aged 18 years or older.\n* Participants without prior buttock augmentation or biopolymer injections in the buttocks.\n* Participants classified as ASA class I and II according to the American Society of Anesthesiologists (ASA) classification system for estimating risk.\n* Participants seeking buttock enhancement, aiming to simply restore the aesthetic curvature of the back.\n* Body mass index between 18.5 and 28.\n* Adequate tissue available to cover the implant(s).\n* Willingness to comply with all study requirements and agree to attend all required follow-up visits.\n* Agreement to return the device to the sponsor in case of explantation.\n\nExclusion Criteria:\n\n* Women with massive weight loss.\n* Buttock ptosis or poor skin quality.\n* Inadequate tissue (e.g., due to radiation damage, ulceration, compromised vascularization, history of compromised healing).\n* Current pregnancy.\n* History of abscesses or infections in the buttock area.\n* History of sensitivity to silicone.\n* Any medical condition such as underweight or obesity according to inclusion criteria, diabetes, autoimmune disease, or severe chronic pulmonary or cardiovascular disease resulting in excessively high surgical risk and significant postoperative complications.\n* History of psychological characteristics that are unrealistic or unreasonable given the risks associated with the surgical procedure.\n* Use of any medication that, according to the investigator's experience, may pose a higher risk of complications or interfere with wound healing capacity, such as corticosteroid treatment or blood-thinning medications (e.g., concomitant treatment with warfarin).\n* Participants who do not reside in the Great Metropolitan Area of Costa Rica, which makes it difficult for them to attend follow-up visits.",true,{"count":58,"type":20},120,[23],"The objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure, involving 120 healthy female participants.\n\nThe main questions it aims to answer are:\n\n* Are the main side effects and complications experienced by participants who underwent a minimally invasive buttock enhancement procedure with Motiva Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator adequately characterized?\n* Can the Motiva Injector®, Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator be successfully utilized, and are any failures in the process detected?\n* Does the Motiva® GEM Channel Separator effectively perform tissue dissection procedures without experiencing operational dysfunctions?\n* Are both the surgeon and the participant satisfied with the procedure outcomes?\n* Is the proper functioning of the Zen microtransponder verified? Participants will undergo a minimally invasive buttock enhancement procedure using the Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator, and have a follow-up of 24 months to see the results.",[62],"Device Safety",[64,65],"Equipment safety","Buttock augmentation","2025-08-20",{"date":68,"type":39},"2025-08-21",{"date":70,"type":39},"2023-04-12",{"date":72,"type":20},"2026-04",{"name":45,"class":46},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100473676","motiva-flora-tissue-expander-pmcf-100473676","NCT05447988","Motiva Flora Tissue Expander PMCF","Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness\u002FPerformance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery","Inclusion Criteria\n\n* The participant gives written informed consent.\n* The participant is genetically female, aged 18 years or older.\n* The participant needs tissue expansion as part of breast reconstruction treatment following mastectomy, which may include immediate reconstruction.\n* The participant is in a suitable clinical condition to allow breast implant placement after tissue expander placement, at the discretion of the investigator.\n* The participant has the physical and cognitive capacity to understand and follow the surgeon's recommendations.\n* Complete radiotherapy at least 1 year before surgery.\n* Partial or total decrease in tumour volume after radiotherapy.\n* The participant is able and willing to comply with all study requirements including attending follow-up appointments.\n* Participant with reasonable surgical risk.\n* Participant with a history of non-metastatic breast cancer.\n* Participant willing to undergo an MRI, CT scan and any other studies if required at surgeon discretion.\n\nFor substudy - MRI \u002F CT - the following additional criteria apply:\n\n\\- Patient is willing to undergo one MRI and one CT anytime during the follow up\n\nExclusion Criteria:\n\n* The participant is pregnant or planning a pregnancy during the first year after surgery or is currently breastfeeding.\n* Participants with implanted devices that may be affected by magnetic fields (pacemakers, drug infusion devices).\n* Participants with abnormal haematological and biochemical values after chemotherapy.\n* Participants with tumour residues in or near the area where tissue expansion is to be performed.\n* Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing or scar deformity.\n* Participants with current or previous infection in the area where the expansion will take place.\n* Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.\n* Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts or radical resection of the pectoralis major muscle.\n* Participant who is included in another pharmacological or device research study.\n* Participants with a previous history of failure of attempted tissue expansion or breast implant placement at the site of intended expansion.\n* Participant with a history of silicone sensitivity.\n* Employees of Establishment Labs or any of its divisions or sites; Researchers or anyone who collaborates on the study or is directly related to a person working for Establishment Labs, sites or commissioned Researchers.",{"count":83,"type":20},136,[23],"The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness\u002FPerformance of Motiva Flora® TE in breast reconstruction surgery.\n\nThe study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.",[87,27],"Breast Tissue Accessory","2024-08-26",{"date":90,"type":39},"2024-08-27",{"date":92,"type":39},"2020-12-14",{"date":94,"type":20},"2026-07-15",{"name":45,"class":46},5,""]