NCT02628496

Confocal Laser Microlaryngoscopy (CLMx)

Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-12-11
• Last updated: 2016-09-09