EctasiaPhase 2NCT00592644
Laser Treatment Of Vascular Lesions On Vocal Cords
A Phase 2 study testing Pulse Dye laser (PDL) and CO2 laser or other traditional surgeries in people with Ectasia, run by Boston University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ectasia
- What is being tested?
- Pulse Dye laser (PDL) and CO2 laser or other traditional surgeries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Laser Atraumatic Treatment Of Ectasias On Vocal Cords
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.
Read the 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.
- Conditions
- Ectasia
- Being tested
- Pulse Dye laser (PDL), CO2 laser or other traditional surgeries
- Keywords
- ectasia, vascular lesions, vocal cords, voice, pulsed dye laser
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Dye laser (PDL)Procedure or surgery
Also called the laser made by Cynosure Inc, Mass
one-time PDL, in 10 subjects
CO2 laser or other traditional surgeriesProcedure or surgery
Also called the laser made by Cynosure Inc. Mass
once-time CO2 laser or other conventional surgeries, in other 10 subjects
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pulse Dye Laser Receives: Procedure: Pulse Dye laser (PDL) |
| 2 | Active comparator | Traditional surgeries Receives: Procedure: CO2 laser or other traditional surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Voice
Measured: 5 months
Secondary outcomes (1)
clearance of lesion
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startMar 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EctasiaStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Investigators
- Zhi Wang, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592644
- Sponsor's protocol ID
- RDC-006853A
- Other IDs
- R21DC006853, R21-006853-2
- Status last verified
- Mar 2011
- First submitted
- 31 Dec 2007
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Atraumatic Treatment Of Ectasias On Vocal Cords
- ClinicalTrials.gov ID
- NCT00592644
- Acronym / sponsor ID
- RDC-006853A
- Conditions
- Ectasia
- Keywords
- ectasia, vascular lesions, vocal cords, voice, pulsed dye laser
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Mar 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Pulse Dye laser (PDL)Pulse Dye Laser |
| 2 | Active comparator | Procedure: CO2 laser or other traditional surgeriesTraditional surgeries |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse Dye laser (PDL)Also: the laser made by Cynosure Inc, Massone-time PDL, in 10 subjects | Procedure or surgery | 1 |
| CO2 laser or other traditional surgeriesAlso: the laser made by Cynosure Inc. Massonce-time CO2 laser or other conventional surgeries, in other 10 subjects | Procedure or surgery | 2 |
Primary outcome
Recovery of Voice
Time frame: 5 months
1 secondary outcome
clearance of lesion
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi Wang, MD principal investigator
Boston University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulse Dye laser (PDL) and CO2 laser or other traditional surgeries in people with Ectasia, run by Boston University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Voice (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.