drugset / Trial / NCT02628496

Confocal Laser Microlaryngoscopy (CLMx)

NCT02628496

NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2015-04
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Background Fluorescein Diagnostic / imaging agent 2.5 ml Intravenous

Indications