Laser Treatment Of Vascular Lesions On Vocal Cords

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00592644
First received: December 31, 2007
Last updated: March 29, 2011
Last verified: March 2011

December 31, 2007
March 29, 2011
March 2005
October 2008   (final data collection date for primary outcome measure)
Recovery of Voice [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00592644 on ClinicalTrials.gov Archive Site
clearance of lesion [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Laser Treatment Of Vascular Lesions On Vocal Cords
Laser Atraumatic Treatment Of Ectasias On Vocal Cords

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ectasia
  • Procedure: Pulse Dye laser (PDL)
    one-time PDL, in 10 subjects
    Other Name: the laser made by Cynosure Inc, Mass
  • Procedure: CO2 laser or other traditional surgeries
    once-time CO2 laser or other conventional surgeries, in other 10 subjects
    Other Name: the laser made by Cynosure Inc. Mass
  • Experimental: 1
    Pulse Dye Laser
    Intervention: Procedure: Pulse Dye laser (PDL)
  • Active Comparator: 2
    Traditional surgeries
    Intervention: Procedure: CO2 laser or other traditional surgeries
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. have SVMs or other small (2.0 mm diameter or less) vasculature-related lesions on vocal fold
  2. Hoarseness or other symptoms of alteration in phonation is persistent least for 3 months
  3. have (or have a high risk of) recurrent vocal fold hemorrhage, SVM enlargement or persistent fold vibratory abnormality
  4. 18 years of age or older
  5. Failure to response to voice training or other non-surgical treatments
  6. Require CO2 laser ablation or other surgical removal of the lesion
  7. Willingness to participate in a 6-month study and adhere to the follow-up schedule
  8. A signed informed consent form

Exclusion Criteria:

  1. Age less than 18 years, or older than 64
  2. Any evidence of mental impairment such that the patient cannot understand the protocol or be in a position to sign the informed consent form
  3. Clinical or histological evidence of malignant conversion
  4. Lesion to be larger than 2.00 mm diameter or those non-vascular lesions
  5. Pregnant women
  6. Severity of disease such that airway patency is in immediate danger
  7. Patients for whom the voice quality is particularly important: including signers, actors, or other similar professions or person who requires a very high voice quality
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00592644
RDC-006853A, R21DC006853, R21-006853-2
No
Zhi Wang, Trustees of Boston University
Boston University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Zhi Wang, MD Boston University
Boston University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP