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Confocal Laser Microlaryngoscopy (CLMx)

NCT02628496 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-09-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions.

In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.

Conditions

  • Laryngeal Dysplasia
  • Laryngeal Neoplasm

Interventions

DRUG

Fluorescein injection, USP 10%

-2.5 ml intravenous 10 minutes before procedure

DEVICE

Confocal laser microlaryngoscopy

PROCEDURE

Biopsy (standard of care)

PROCEDURE

KTP laser photoablation (standard of care)

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Joseph Bradley, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-01-31
Completion
2017-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02628496 on ClinicalTrials.gov