Laryngeal Neoplasm Clinical Trial
Official title:
Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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