Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)

Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01626638

Acronym

MEC ORL

Enrollment

Registered

2012-06-25

Start date

2013-02-01

Completion date

2017-05-24

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pharyngo Laryngeal Tumors, Pre-malignant Pharyngo Laryngeal Tumors

Keywords

Patients with malignant and pre-malignant pharyngo laryngeal tumors

Brief summary

The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

Interventions

PROCEDUREConfocal Micro Endoscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal * \> 18 years * signed ICF

Exclusion criteria

* Persons deprived of liberty * Patients with history of allergy to patent blue * Pregnant women or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Diagnostic correlation between confocal micro endoscopy and conventional histology	at an average of 18 months

Secondary

Measure	Time frame
Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis	At the time of the biopsy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026