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Laser Treatment Of Vascular Lesions On Vocal Cords

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592644
First Posted: January 14, 2008
Last Update Posted: March 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
Boston University
  Purpose
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.

Condition Intervention Phase
Ectasia Procedure: Pulse Dye laser (PDL) Procedure: CO2 laser or other traditional surgeries Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laser Atraumatic Treatment Of Ectasias On Vocal Cords

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Recovery of Voice [ Time Frame: 5 months ]

Secondary Outcome Measures:
  • clearance of lesion [ Time Frame: 5 months ]

Enrollment: 7
Study Start Date: March 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pulse Dye Laser
Procedure: Pulse Dye laser (PDL)
one-time PDL, in 10 subjects
Other Name: the laser made by Cynosure Inc, Mass
Active Comparator: 2
Traditional surgeries
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592644


Sponsors and Collaborators
Boston University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Zhi Wang, MD Boston University
  More Information

Responsible Party: Zhi Wang, Trustees of Boston University
ClinicalTrials.gov Identifier: NCT00592644     History of Changes
Other Study ID Numbers: RDC-006853A
R21DC006853 ( U.S. NIH Grant/Contract )
R21-006853-2
First Submitted: December 31, 2007
First Posted: January 14, 2008
Last Update Posted: March 31, 2011
Last Verified: March 2011

Keywords provided by Boston University:
ectasia
vascular lesions
vocal cords
voice
pulsed dye laser

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical