Clinical trial · Interventional
Identification of Oral Lesions Through an Autofluorescence System
Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
NCT05942794CI-TRIAL-00125289completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autofluorescence | — | UNRESOLVED | — |
| Keratosis | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Disease | — | UNRESOLVED | — |
| Oral Leukoplakia | — | UNRESOLVED | — |
| Oral Lichen Planus | — | UNRESOLVED | — |
| Secondary Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening examination | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening examination
- description
- All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.
- interventionNames
- Device: Screening examination
Primary outcomes (2)
- measure
- Clinical change of oral mucosa
- timeFrame
- baseline and after 21 days
- description
- Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance
- measure
- Fluorescence change of oral mucosa
- timeFrame
- baseline and after 21 day
- description
- Presence of a mucosal area with reduced or increased fluorescence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female; * Age ≥ 18 years; * Non-smokers and smokers Exclusion Criteria: * Cancer patients; * Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.
References
Publications (0)
Data not yet available
No reference posted for this study.