In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy

Conditions

• Endonasal Surgery
• Endoscopic Sinus Surgery
• Olfactory Dysfunction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CONVIVO system — DEVICE
  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.
• Conventional histologic evaluation — OTHER
  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.
• Fluorescein injection, USP 10% — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

36 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

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. [ Time Frame: On day of Surgery, Day 0 ]

Central Contacts

• Michaela M Geffert, MS
  603-650-2054
  [email protected]
• Ryan E Little, MD
  603-650-8123
  [email protected]

Locations (1)

Find similar trials in Lebanon, NH

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