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
2 other identifiers
observational
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
Study Completion
Last participant's last visit for all outcomes
July 31, 2027
April 23, 2026
April 1, 2026
10 months
April 16, 2026
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the feasibility of in vivo CLE imaging of the olfactory cleft and nasal turbinate and determine whether CLE features correlate with validated psychophysical olfactory testing and patient-reported quality-of-life measures.
(1) High feasibility (≥85% interpretable images); (2) identifiable CLE signatures associated with OD severity; (3) significant correlations between CLE features, TDI scores, and symptom burden.
On day of Surgery, Day 0
Secondary Outcomes (1)
Compare in vivo CLE imaging features with histopathologic findings from superior turbinate tissue, when available, to identify candidate in vivo imaging biomarkers.
On day of Surgery, Day 0
Study Arms (2)
Target Group (Patients with Olfactory Complaints)
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.
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.
Interventions
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.
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.
Sodium fluorescein will be administered intravenously or topically (applied directly to nasal mucosa) at doses of 5-10 mg/kg (not exceeding 20 mg/kg cumulative). Administration will be performed by the anesthesia team in the operating room.
Eligibility Criteria
Adults undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible at Dartmouth Hitchcock Medical Center.
You may qualify if:
- Adults aged ≥18 years
- Undergoing endoscopic sinus or endonasal skull base surgery while under - general anesthesia where the nasal turbinate is accessible
- Able to complete study questionnaires and psychophysical smell testing
- Able to provide informed consent.
You may not qualify if:
- Known allergy or hypersensitivity to fluorescein
- Pregnancy
- Medical instability precluding participation
- Severe anatomic obstruction preventing safe access to the olfactory cleft and nasal turbinate
- Any other safety concern identified by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03755, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Sinus Research Center Assistant Professor of Surgery, Geisel School of Medicine, Dartmouth
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 23, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share