[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634971":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":38,"locations":48,"responsibleParty":65,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":10,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":94,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Dartmouth-Hitchcock Medical Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Target Group (Patients with Olfactory Complaints)",null,"Patients who have olfactory complaints and are undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible, per their standard of care.",[13,14,15],"Device: CONVIVO system","Other: Conventional histologic evaluation","Drug: Fluorescein injection, USP 10%",{"label":17,"type":10,"description":18,"interventionNames":19},"Control Group","Controls will consist of surgical patients without subjective olfactory complaints and with expected normal psychophysical testing. Patients who are already undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible, per their standard of care.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DEVICE","CONVIVO system","Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Following image acquisition, a pathologist present in the operating room, will review and capture each image.",[17,9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Conventional histologic evaluation","Following image acquisition, if clinically indicated, the tissue region imaged with the CONVIVO system will then be biopsied. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.",[17,9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Fluorescein injection, USP 10%","Sodium fluorescein will be administered intravenously or topically (applied directly to nasal mucosa) at doses of 5-10 mg\u002Fkg (not exceeding 20 mg\u002Fkg cumulative). Administration will be performed by the anesthesia team in the operating room.",[17,9],[36,37],"AK-FLUOR","FNa",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Michaela M Geffert, MS","CONTACT","603-650-2054","Michaela.M.Geffert@Hitchcock.org",{"name":45,"role":41,"phone":46,"phoneExt":10,"email":47},"Ryan E Little, MD","603-650-8123","Ryan.E.Little@Hitchcock.org",[49],{"facility":5,"status":10,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Lebanon","New Hampshire","03755","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-72.25176,43.64229,{"lat":59,"lon":58},[62,63],{"name":45,"role":41,"phone":46,"phoneExt":10,"email":47},{"name":45,"role":64,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ryan.E.Little","Director of the Sinus Research Center Assistant Professor of Surgery, Geisel School of Medicine, Dartmouth",[69],{"name":70,"class":71},"National Center for Advancing Translational Sciences (NCATS)","NIH","100634971","in-vivo-imaging-of-the-olfactory-epithelium-using-confocal-laser-endomicroscopy-100634971",false,"NCT07546617","In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy","In Vivo Imaging of Olfactory Epithelium in Humans With Olfactory Impairment Using Confocal Laser Endomicroscopy","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Undergoing endoscopic sinus or endonasal skull base surgery while under - general anesthesia where the nasal turbinate is accessible\n* Able to complete study questionnaires and psychophysical smell testing\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to fluorescein\n* Pregnancy\n* Medical instability precluding participation\n* Severe anatomic obstruction preventing safe access to the olfactory cleft and nasal turbinate\n* Any other safety concern identified by the investigator","ALL","18 Years",{"count":82,"type":83},36,"ESTIMATED","OBSERVATIONAL","This research is being done to better characterize the part of the nose that helps us smell. Currently, the only ways to study smell loss mostly rely on how people report it, rather than being able to see the underlying structures directly. In this study, we will use a special microscope (Confocal Laser Endomicroscopy (CLE)), originally developed for brain tissue, to look at the part of the nose that helps to detects smell. We hope to identify the tiny structures in that area and see how they might be different in people who have smell loss compared to those who do not.",[87,88,89],"Endonasal Surgery","Endoscopic Sinus Surgery","Olfactory Dysfunction",[91,88,92,93,89],"Confocal Laser Endomicroscopy","Smell Loss","Endonasal Skull Base Surgery","NOT_YET_RECRUITING","2026-04-16",{"date":97,"type":98},"2026-04-23","ACTUAL",{"date":100,"type":83},"2026-07-01",{"date":102,"type":83},"2027-07-31",{"name":5,"class":6},1]