Laser Treatment Of Vascular Lesions On Vocal Cords - Full Text View

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00592644

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 II

MedlinePlus related topics: Surgery

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Laser Atraumatic Treatment Of Ectasias On Vocal Cords

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:

Recovery of Voice [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clearance of lesion [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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
1: Experimental Pulse Dye Laser	Procedure: Pulse Dye laser (PDL) one-time PDL, in 10 subjects
2: Active Comparator Traditional surgeries	Procedure: CO2 laser or other traditional surgeries once-time CO2 laser or other conventional surgeries, in other 10 subjects

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592644

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Zhi Wang, MD

Boston University

More Information

No publications provided

Responsible Party:	Trustees of Boston University ( Zhi Wang )
Study ID Numbers:	RDC-006853A, R21-006853-2
Study First Received:	December 31, 2007
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00592644 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

ectasia
vascular lesions
vocal cords
voice
pulsed dye laser

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Dilatation, Pathologic

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Dilatation, Pathologic

ClinicalTrials.gov processed this record on May 07, 2009