[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ss. Cyril and Methodius University of Skopje\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":56},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100640349","niraf-guided-parathyroid-identification-during-thyroidectomy-100640349",false,"NCT07617584","NIRAF-Guided Parathyroid Identification During Thyroidectomy","Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy","Inclusion Criteria:\n\n* Age 18 years or older.\n* For Component A: planned thyroidectomy of any extent with an intact specimen available for ex vivo evaluation.\n* For Component B: planned total or completion thyroidectomy.\n* Ability to provide written informed consent before surgery.\n* Willingness to comply with routine postoperative laboratory testing and follow-up when feasible.\n\nExclusion Criteria:\n\n* Known pre-existing hypoparathyroidism or prior parathyroid surgery.\n* Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator.\n* Pregnancy.\n* For Component B only: gross nodal disease or a surgical plan requiring extensive nodal packet dissection in the current study phase.\n* Any condition that, in the judgment of the investigator, would make participation unsafe or compromise protocol adherence.","ALL","18 Years",{"count":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single-site, two-component prospective study evaluating whether near-infrared autofluorescence (NIRAF) imaging can improve intraoperative identification of parathyroid glands during thyroidectomy and reduce postoperative hypocalcemia.\n\nThe investigational platform is a modified wearable stereoscopic goggle system configured for label-free NIRAF imaging. Parathyroid tissue is excited with near-infrared light at approximately 780 nm and emits autofluorescence centered near 800 nm. No injected dye or external contrast agent is used. The goggles are used only during a brief mapping interval after thyroid exposure and for ex vivo interrogation of the resected thyroid specimen.\n\nComponent A is a prospective observational run-in validation cohort of 30 adults undergoing thyroidectomy of any extent. NIRAF-positive foci on the intact thyroidectomy specimen are suture-marked and correlated with targeted pathology.\n\nComponent B is a randomized clinical study of 250 adults undergoing total or completion thyroidectomy. Participants are randomized 1:1 to standard surgery or standard surgery plus brief in vivo NIRAF mapping, ex vivo specimen interrogation, and rescue autotransplantation when indicated. The primary outcome for Component B is transient biochemical hypocalcemia on postoperative day 1, defined using albumin-corrected serum calcium.",[26,27,28,29,30,31],"Hypocalcemia","Hypoparathyroidism","Thyroid Diseases","Goiter, Nodular","Thyroid Nodule","Thyroidectomy",[33,34,35,36,31,37,38,39,40,41,42,43,44],"Near-Infrared Autofluorescence","NIRAF","Parathyroid Identification","Parathyroid Preservation","Completion Thyroidectomy","Total Thyroidectomy","Postoperative Hypocalcemia","Intact Parathyroid Hormone","iPTH","Rescue Autotransplantation","Wearable Imaging","Post-thyroidectomy hypocalcemia","NOT_YET_RECRUITING","2026-05-29",{"date":48,"type":49},"2026-06-01","ACTUAL",{"date":48,"type":20},{"date":52,"type":20},"2029-12-01",{"name":54,"class":55},"Ss. Cyril and Methodius University of Skopje","OTHER",""]