Clinical Trial: Confocal Laser Microlaryngoscopy (CLMx)

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome:

  • Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe [ Time Frame: Day of surgery (Day 1) ]
  • Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe [ Time Frame: Day of surgery (Day 1) ]
  • Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe [ Time Frame: Day of surgery (Day 1) ]
    -If the prevalence of the disease in the population is known, the accuracy of the test can be calculated bases on prevalence sensitivity, specificity using the formula: Sensitivity*Prevalence + Specificity*(1-Prevalence)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Washington University School of Medicine

Dates:
Date Received: December 9, 2015
Date Started: April 2015
Date Completion: January 2017
Last Updated: September 8, 2016
Last Verified: September 2016