[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"reconstructive-surgical-procedures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:reconstructive-surgical-procedures":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100605555","leica-microsystems-sponsored-study-to-collect-and-confirm-clinical-data-on-the-performance-of-the-glow800-device-when-used-in-accordance-with-its-intended-use-100605555",false,"NCT07164040","Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.","Fluorescence Visualization and Image Quality Evaluation of Digital Visualization During Standard of Care Procedure in the Cerebral Vascular Area as Well as Blood Flow During Plastic and Reconstructive Surgery (PRS) (Leica GLOW800)","IMED-GLOW800","Inclusion Criteria:\n\nCandidates for the study must be appropriate patients for surgical interventions in the cerebral vascular area or for plastic and reconstructive surgery and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.\n\n1. Participants must be 18 years of age or older at the time of signing the informed consent.\n2. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.\n3. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use.\n4. The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study\n\nExclusion Criteria:\n\nCandidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.\n\n1. Known allergy to Indocyanine Green (ICG) cyanine dye.\n2. Any uncontrolled systemic condition that may adversely affect the surgical outcome.\n3. Patients holding United States citizenship.\n4. Severe iodine-induced reactions to macromolecular iodine-containing compounds (e.g., iodinated contrast media, iodine-based antiseptics, or drugs like amiodarone), especially if the reaction involved anaphylaxis or respiratory compromise.","ALL","18 Years",{"count":20,"type":21},29,"ESTIMATED","OBSERVATIONAL","This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in the cerebral vascular area and plastic and reconstructive surgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.",[25,26,27,28],"Reconstructive Surgical Procedures","Plastic Surgery","Vascular Surgical Procedure","Cerebrovascular Disorder",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"GLOW800","Indocyanine-green (ICG)","Near Infrared","plastic and reconstructive surgery","ARveo8X","Surgical Microscope","Fluorescence imaging","Cerebrovascular surgery","Intraoperative visualization","Post-market clinical follow-up (PMCF)","Image quality assessment","3D visualization","Heads-up surgery","Vascular imaging","Digital surgical workflow","RECRUITING","2026-01-16",{"date":48,"type":49},"2026-01-20","ACTUAL",{"date":48,"type":21},{"date":52,"type":21},"2027-07-30",{"name":54,"class":55},"Leica Microsystems (Schweiz) AG","INDUSTRY",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":64,"minAge":18,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100495872","a-retrospective-assessment-of-ovitex-prs-ovitex-100495872","NCT05736848","A Retrospective Assessment of OviTex PRS (OviTex)","A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction","PRS","Inclusion Criteria:\n\n1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.\n2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.\n3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).\n\nExclusion Criteria:\n\n1. Patient received a textured permanent breast implant.\n2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.\n3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery.\n\nAdditional prospective inclusion criteria (if applicable):\n\n1\\. Patient agrees to return in-person for prospective portion including the completion of photographs.\n\nAdditional prospective exclusion criteria (if applicable):\n\n1\\. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.","FEMALE","75 Years",{"count":67,"type":21},200,"The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.",[25],"2025-08-14",{"date":72,"type":49},"2025-08-15",{"date":74,"type":49},"2022-09-27",{"date":76,"type":21},"2026-12-31",{"name":78,"class":55},"Tela Bio Inc",11,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":64,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":107,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100593584","impact-of-nipple-reconstruction-in-mastectomized-patients-using-cross-linked-hyaluronic-acid-injection-100593584","NCT07008339","Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.","RECHIAL","* Quantitative Phase\n* Inclusion Criteria:\n\nWomen over 18 years of age, or with parental or legal guardian consent.\n\nAt least one of the following criteria:\n\nWomen undergoing their first nipple-areola complex (NAC) reconstruction through micropigmentation and\u002For:\n\nNo previous neo-nipple surgery, either unilaterally or bilaterally.\n\nSurgical reconstruction of the areola.\n\nSurgical reconstruction of the NAC with subsequent retraction of the neo-nipple.\n\nMore than 6 months since their last surgery.\n\n\\- Exclusion Criteria:\n\nAllergy to hyaluronic acid.\n\nPoor tolerance to needle injections.\n\nWithdrawal Criteria:\n\nParticipant's voluntary decision.\n\nComplications associated with the technique (allergy, hematoma, etc.).\n\nClinical deterioration preventing the woman from continuing in the study.\n\n\\- Qualitative Phase\n\nParticipant Profile Characteristics: For the qualitative phase, women who have received NAC reconstruction with HA will be invited to participate, following the maximum variation criterion. To ensure the inclusion of participants with diverse characteristics and capture a wide range of perspectives and experiences on the phenomenon under study, women of varying ages, with different breast cancer diagnoses, and histories of various oncological, surgical, and therapeutic treatments will be selected.",{"count":88,"type":21},138,"INTERVENTIONAL",[91],"NA","This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes.\n\nA sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using the Spanish BREAST-Q, a custom satisfaction tool, and calipers.\n\nPhase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software.\n\nThis is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications.\n\nThis minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery.\n\nThe study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.",[94,95,96,97,98,99,100,25,101,102,103,104,105,106],"Breast Neoplasms","Mastectomy","Mammaplasty","Nipple Disorder","Tattooing","Hyaluronic Acid","Dermal Fillers","Quality of Life","Self Concept","Body Image","Patient Satisfaction","Breast Reconstruction","Nipple Reconstruction",[108,95,105,109,106,110,99,100,111,98,103,101,112,113,104,114],"Breast Cancer","Nipple-Areola Complex Reconstruction","Areola Reconstruction","Micropigmentation","Postmastectomy Reconstruction","Cross-linked Hyaluronic Acid","Breast Cancer Survivors","2025-06-04",{"date":117,"type":49},"2025-06-06",{"date":119,"type":49},"2023-06-02",{"date":121,"type":21},"2029-07-02",{"name":123,"class":124},"Germans Trias i Pujol Hospital","OTHER",1]