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Laser Treatment Of Vascular Lesions On Vocal Cords

Primary Purpose

Ectasia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pulse Dye laser (PDL)
CO2 laser or other traditional surgeries
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectasia focused on measuring ectasia, vascular lesions, vocal cords, voice, pulsed dye laser

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Pulse Dye Laser

    Traditional surgeries

    Outcomes

    Primary Outcome Measures

    Recovery of Voice

    Secondary Outcome Measures

    clearance of lesion

    Full Information

    First Posted
    December 31, 2007
    Last Updated
    March 29, 2011
    Sponsor
    Boston University
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00592644
    Brief Title
    Laser Treatment Of Vascular Lesions On Vocal Cords
    Official Title
    Laser Atraumatic Treatment Of Ectasias On Vocal Cords
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Boston University
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ectasia
    Keywords
    ectasia, vascular lesions, vocal cords, voice, pulsed dye laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Pulse Dye Laser
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Traditional surgeries
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulse Dye laser (PDL)
    Other Intervention Name(s)
    the laser made by Cynosure Inc, Mass
    Intervention Description
    one-time PDL, in 10 subjects
    Intervention Type
    Procedure
    Intervention Name(s)
    CO2 laser or other traditional surgeries
    Other Intervention Name(s)
    the laser made by Cynosure Inc. Mass
    Intervention Description
    once-time CO2 laser or other conventional surgeries, in other 10 subjects
    Primary Outcome Measure Information:
    Title
    Recovery of Voice
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    clearance of lesion
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have SVMs or other small (2.0 mm diameter or less) vasculature-related lesions on vocal fold Hoarseness or other symptoms of alteration in phonation is persistent least for 3 months have (or have a high risk of) recurrent vocal fold hemorrhage, SVM enlargement or persistent fold vibratory abnormality 18 years of age or older Failure to response to voice training or other non-surgical treatments Require CO2 laser ablation or other surgical removal of the lesion Willingness to participate in a 6-month study and adhere to the follow-up schedule A signed informed consent form Exclusion Criteria: Age less than 18 years, or older than 64 Any evidence of mental impairment such that the patient cannot understand the protocol or be in a position to sign the informed consent form Clinical or histological evidence of malignant conversion Lesion to be larger than 2.00 mm diameter or those non-vascular lesions Pregnant women Severity of disease such that airway patency is in immediate danger 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhi Wang, MD
    Organizational Affiliation
    Boston University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Laser Treatment Of Vascular Lesions On Vocal Cords

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