Laser Treatment Of Vascular Lesions On Vocal Cords
Laser Atraumatic Treatment Of Ectasias On Vocal Cords
3 other identifiers
interventional
7
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2005
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 31, 2007
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMarch 31, 2011
March 1, 2011
3.6 years
December 31, 2007
March 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recovery of Voice
5 months
Secondary Outcomes (1)
clearance of lesion
5 months
Study Arms (2)
1
EXPERIMENTALPulse Dye Laser
2
ACTIVE COMPARATORTraditional surgeries
Interventions
one-time PDL, in 10 subjects
once-time CO2 laser or other conventional surgeries, in other 10 subjects
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi Wang, MD
Boston University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 31, 2007
First Posted
January 14, 2008
Study Start
March 1, 2005
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 31, 2011
Record last verified: 2011-03