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
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
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
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
NCT ID
NCT00592644
First Posted
December 31, 2007
Last Updated
March 29, 2011
Sponsor
Boston University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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
Learn more about this trial
Laser Treatment Of Vascular Lesions On Vocal Cords
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