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ACTIVE NOT RECRUITING
NCT07546617
PHASE4

In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy

Sponsor: Dartmouth-Hitchcock Medical Center

View on ClinicalTrials.gov

Summary

This research is being done to better characterize the part of the nose that helps people 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, the team 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. The study team hopes 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.

Official title: In Vivo Imaging of Olfactory Epithelium in Humans With Olfactory Impairment Using Confocal Laser Endomicroscopy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-04-28

Completion Date

2027-07-31

Last Updated

2026-08-14

Healthy Volunteers

Yes

Interventions

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.

DRUG

Fluorescein injection, USP 10%

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.

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States