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In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv4
  3. Phase changed: Phase 4 → Early Phase 1v3
  4. Phase changed: not specified → Phase 4v2 Show 5 more changesShow less
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Start date changed from estimate of Jul 1, 2026 to Apr 28, 2026
    • Interventions: CONVIVO system (Device), Conventional histologic evaluation (Other), Fluorescein injection, USP 10% (Drug) to CONVIVO system (Device), Fluorescein injection, USP 10% (Drug)
    • Site contact updated
    • Study description expanded, about 2 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Participation in the study includes completing a smell test (Sniffin' Sticks Extended test), a cognitive screening test, and two questionnaires.
Trial Details
NCT Number NCT07546617
Lead Sponsor Dartmouth-Hitchcock Medical Center
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)		 Endonasal Surgery, Endoscopic Sinus Surgery, Olfactory Dysfunction
Related terms Anosmia
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov