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More info
You can access this
clinical trial
if you have
Laryngeal Dysplasia or Laryngeal Neoplasm
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Drug: Fluorescein injection, USP 10%
  • Device: Confocal laser microlaryngoscopy
  • Procedure: Biopsy (standard of care)
  • Procedure: KTP laser photoablation (standard of care)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02628496. The sponsor of the trial is Washington University School of Medicine and it is looking for 0 volunteers for the current phase.
Official trial title:
Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions