[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plastic-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plastic-surgery":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":56},"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",3,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100610896","preoperative-maxillary-nerve-block-and-remifentanil-use-in-septorhinoplasty-100610896","NCT07233538","Preoperative Maxillary Nerve Block and Remifentanil Use in Septorhinoplasty","Effect of Preoperative Ultrasound-guided Bilateral Maxillary Nerve Block Via the Pterygopalatine Fossa on Intraoperative Remifentanil Use in Septorhinoplasty","PRISM","Inclusion Criteria:\n\n* Those with an ASA (American Society of Anesthesiologists) score of I-II\n* Those with a body mass index (BMI) between 18 and 30\n* Those scheduled for elective surgery\n* Those who are fully cooperative Patients who meet the criteria for septorhinoplasty surgery\n\nExclusion Criteria:\n\n* Conditions that constitute a relative contraindication to regional anesthesia (e.g., coagulation disorders, thrombocytopenia, severe valvular heart disease, local infection at the injection site, allergy to local anesthetic agents)\n* International Normalized Ratio (INR) \\> 1.5\n* Facial paralysis or a history of facial paralysis\n* History of central nervous system vascular disease\n* Presence of neuropathy\n* History of surgery in the region where the block will be performed\n* American Society of Anesthesiologists (ASA) physical status classification of III or higher\n* Patients who do not want to participate in the study\n* Patients with chronic pain or chronic opioid use\n* Patients with alcohol, substance or drug addiction\n* Patients with limited cooperation such as dementia, psychiatric disorders\n* Pregnant and breastfeeding patients will be excluded from the study.\n* Patients who cannot communicate in their native language will be excluded from the study","65 Years",{"count":67,"type":21},90,"INTERVENTIONAL",[70],"NA","Septorhinoplasty is generally a prolonged surgical procedure that frequently involves osteotomy, which may lead to increased intraoperative remifentanil requirements. Moreover, it is often associated with significant bleeding due to the dense capillary network of the nasal region, making the maintenance of low-to-normal blood pressure preferable during surgery. Consequently, achieving stable hemodynamics and providing sufficient analgesia throughout the procedure is essential.\n\nThis study aims to evaluate the effects of bilateral maxillary nerve block on intraoperative remifentanil consumption and postoperative analgesic efficacy in patients undergoing Septorhinoplasty. A total of 90 patients will be included in the study. Forty-five patients (Group M) will undergo Septorhinoplasty under general anesthesia combined with bilateral maxillary nerve block, while the remaining 45 patients (Group N) will receive general anesthesia alone.\n\nIn the preoperative phase, a bilateral maxillary nerve block will be performed under ultrasound guidance via the pterygopalatine fossa. During the intraoperative period, total remifentanil consumption will be recorded, alongside assessments of hemodynamic stability, sevoflurane consumption, extubation time, intraoperative bleeding volume, and the satisfaction levels of both the anesthesiologist and the surgeon.\n\nIn the postoperative period, patient satisfaction, pain scores at 0, 1, 2, 4, 6, 12, 18, and 24 hours as well as at 1 month (measured using the Visual Analog Scale - VAS), additional analgesic requirements, and Quality of Recovery-15 (QoR-15) scores (assessed on preoperative day 1, postoperative day 1, and at 1 month) will be evaluated.",[73,26,74,75,76,77],"Head and Neck Surgery","Rhinoplasty","Pain","Regional Anaesthesia","Nerve Blocks","2025-11-17",{"date":80,"type":49},"2025-11-18",{"date":82,"type":49},"2025-08-20",{"date":84,"type":21},"2026-12-08",{"name":86,"class":87},"Ankara Etlik City Hospital","OTHER_GOV",1]