NCT00592644

Laser Treatment Of Vascular Lesions On Vocal Cords

Laser Atraumatic Treatment Of Ectasias On Vocal Cords

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the voice. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel abnormalities in surface tissue, through its high selectivity for destroying targeted blood vessels while sparing normal tissue. However, there is no study to determine its clinical benefit for treatment of SVMs on vocal fords. In this proposed study, we plan to make such a determination.We will determine whether PDL will produce better and quicker voice improvement than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM. We expect that this less invasive laser treatment will provide an ideal and excellent option for this disease.

Detailed description

Clinically, small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the voice. Currently, this problem is treated with endoscopic microsurgery with the use of a Carbon dioxide (CO2) laser or other microsurgeries. However, those treatments are unsatisfactory because of their invasive nature. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel abnormalities in surface tissue, through its high selectivity for destroying targeted blood vessels while sparing normal tissue. Even thought this process has been in use clinically for the past 5 years, there is no study to determine its clinical benefit for treatment of SVMs on vocal fords, by comparing it with routine surgeries. In this proposed study, we plan to make such a determination, by comparing the voice recovery and voice improvement between this laser and those routine surgeries (with CO2 laser or "cold" instrument). Our specific aim is to determine whether PDL will produce better and quicker voice improvement than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM. This is the first study to determine clinical benefit of the microvascular targeting (MVT) technique of laser to treat vocal fold SVMs, by a comparison of the voice results between these two groups. We expect that this less invasive laser treatment will provide an ideal and excellent alternative to current surgical approaches for treatment of this disease.

Conditions

• Ectasia

Interventions

Type	Name	Description
PROCEDURE	Pulse Dye laser (PDL)	one-time PDL, in 10 subjects
PROCEDURE	CO2 laser or other traditional surgeries	once-time CO2 laser or other conventional surgeries, in other 10 subjects

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-01-14
• Last updated: 2011-03-31