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Comparison of BL and KTP Laser for Treatment of Benign Vocal Fold Lesions

NCT04513392 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-08-14

No results posted yet for this study

Summary

Preliminary investigations suggest that a novel blue light (BL) laser with a wavelength of 445nm is comparable to the commonly utilized KTP laser (532nm) for treatment of laryngeal pathologies. An animal study by the Principal Investigators showed that the blue light laser results in significantly less vocal fold scarring compared to the KTP laser, suggesting that the blue light laser may be a better instrument for treating vocal fold disease. However, there are no clinical studies directly comparing the two lasers on treatment of vocal fold pathology. The goal of the proposed study is to directly compare treatment outcomes of the BL laser and KTP laser for benign vocal fold lesions. All laser treatments will be performed in the office under local anesthesia as per standard of care. Outcome variables of interest will be compared between groups, including Voice Handicap Index-10 (VHI-10) score (measured at baseline, 1 week, 1 month, and 3 months post procedure), laryngeal stroboscopic findings (1 and 3 months post procedure), and intra-operative pain. This study will provide support that the blue light laser is a comparable alternative to the KTP laser and allow the addition of this novel laser to the armamentarium for treating vocal fold diseases.

Conditions

  • Voice Disorders
  • RRP

Interventions

PROCEDURE

Laser treatment

A flexible laser fiber will be utilized via a channelled laryngoscope to ablate the benign laryngeal lesions as per standard of care.

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-11-01
Completion
2021-11-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04513392 on ClinicalTrials.gov