Voice DisordersNCT04513392
Comparison of BL and KTP Laser for Treatment of Benign Vocal Fold Lesions
A study testing Laser treatment in people with Voice Disorders and RRP, run by University of Toronto.
Trial summary
Preliminary investigations suggest that a novel blue light (BL) laser with a wavelength of 445nm is comparable to the commonly utilized KTP laser (532nm) for treatment of laryngeal pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Voice Disorders, RRP
- What is being tested?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Nov 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Male and female, aged ≥ 18 years; and
- Diagnosed with benign vocal fold lesions such as papillomas and polyps and who are candidates for elective in office laser treatment for these lesions.
Who cannot join
- < 18 years old;
- Current smokers;
- Vocal fold lesions such as vocal fold leukoplakia and vocal fold cancer;
- Systemic steroid use; and
- History of systemic illness that can affect wound healing.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Treatment Outcome of Blue Light Laser and KTP Laser for Benign Vocal Fold Lesions: A Randomized Trial
Preliminary investigations suggest that a novel blue light (BL) laser with a wavelength of 445nm is comparable to the commonly utilized KTP laser (532nm) for treatment of laryngeal pathologies. An animal study by the Principal Investigators showed that the blue light laser results in significantly less vocal fold scarring compared to the KTP laser, suggesting that the blue light laser may be a better instrument for treating vocal fold disease. However, there are no clinical studies directly comparing the two lasers on treatment of vocal fold pathology. The goal of the proposed study is to directly compare treatment outcomes of the BL laser and KTP laser for benign vocal fold lesions. All laser treatments will be performed in the office under local anesthesia as per standard of care. Outcome variables of interest will be compared between groups, including Voice Handicap Index-10 (VHI-10) score (measured at baseline, 1 week, 1 month, and 3 months post procedure), laryngeal stroboscopic findings (1 and 3 months post procedure), and intra-operative pain. This study will provide support that the blue light laser is a comparable alternative to the KTP laser and allow the addition of this novel laser to the armamentarium for treating vocal fold diseases.
Read the detailed description
A novel blue light (BL) laser, TruBlue surgical laser, has recently been approved by Health Canada for use in the larynx. It has a wavelength of 445nm, which is within the same visible light spectrum as the KTP laser (532nm). It is a photoangiolytic laser like the KTP and can be delivered through a flexible fiber and therefore allowing the procedure to be performed in clinic under local anesthesia. Other advantages include better tissue cutting and increased portability. No clinical studies in the literature have directly compared the BL laser and KTP laser in the treatment of benign vocal fold lesions. The main objective of this proposal is to compare between-group differences in patient perception of voice handicap between BL laser and KTP laser for treatment of benign vocal fold lesions at 3 months compared to baseline. Given the PIs' previous work comparing vocal fold scarring induced by these two lasers in a rat model, we hypothesize that the blue light laser will be equally effective at treating benign vocal fold lesions as the KTP laser, resulting in improved VHI-10 score at 3 months post laser treatment compared to baseline.
The KTP laser has been a workhorse laser used in Otolaryngology/Laryngology for awake treatments of vocal fold lesions. However, it is phasing out of the market as the laser itself as well as the laser fibers compatible with this laser are no longer being manufactured. Therefore, Laryngologists are eagerly looking for an alternative to the KTP laser in order to fill this gap in care. The BL laser is cheaper in costs and more portable compared to the KTP. It also has better tissue cutting abilities which can be useful in treating certain vocal fold lesions such as vocal fold cancer and subglottic stenosis. This study is the first to directly compare treatment outcomes between the BL laser and KTP laser for vocal fold lesions. If the BL laser is shown to be comparable to the KTP in this clinical study, it lends support that this novel laser is indeed an excellent alternative to the KTP laser and can therefore be incorporated into routine patient care.
- Conditions
- Voice Disorders, RRP
- Being tested
- Laser treatment
- Keywords
- KTP, Blue light laser, laryngology, in office procedures
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentProcedure or surgery
A flexible laser fiber will be utilized via a channelled laryngoscope to ablate the benign laryngeal lesions as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| KTP laser treatment | Active comparator | All participants will complete a paper Voice Handicap Index-10 (VHI-10) questionnaire and laryngeal stroboscopy examination at baseline. Local anesthesia will be administered as per standard of care for in-office laryngeal procedures. KTP laser will be utilized to ablate the lesion of interest. Immediately following the procedure, participants will complete a VAS pain scale on paper. Participants will be asked to exercise 3 days of absolute voice rest following the procedure. All patients will have follow-up clinic appointments on POD 7, POD 30, and POD 90 after surgery. At each of the follow-up visit, the patients will fill out a paper VHI-10 questionnaire and undergo stroboscopic examination to assess vocal fold vibratory properties and closure, as well as residual lesions. During the first week post procedure, the participants will continue to complete a daily VAS at home for pain assessment. Receives: Procedure: Laser treatment |
| BL laser treatment | Experimental | The only difference in study procedures between the experimental arm and the control arm is that the experimental arm will use the BL laser. The post-operative instructions and follow-up schedule are identical. Receives: Procedure: Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index-10 (VHI-10)
VHI-10 is a validated 10-item questionnaire that quantifies the impact of voice limitations on the individual's overall daily function. It has a Cronbach's alpha of 0.90, indicating high internal consistency. It ranges from a score of 0 to 40. The higher the score, the worse the patient's perception of voice handicap. A score of ≥11 is abnormal. It is a standard of care at the Laryngology outpatient clinic at St. Michael's Hospital for patients to fill out the VHI-10 on paper independently before each clinic visit.
Measured: Change in VHI-10 score at 3 months
Secondary outcomes (2)
Laryngeal stroboscopy
Laryngeal stroboscopy is controlled light illumination of the vocal folds during phonation timed to the frequency of the patient's voice. Images acquired during these flashes provide a slow motion-like view of vocal fold vibration during sound production to allow examination of vocal fold vibration and closure. Vocal fold mucosal vibration and closure pattern have been shown to be reliable and valid parameters to assess vocal fold healing after surgery of the vocal folds. These parameters will be collected as per standard of care at baseline, POD 7, POD 30, and POD 90 and will be judged by a blinded assessor (i.e. participant's non-treating Laryngologist who is not involved in his/her care) from video capture.
Measured: 3 months post op compared with baseline
VAS pain scale
A Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic which ranges across a continuum of values and cannot easily be directly measured. It will be ranked from a continuum scale of 1 to 10.
Measured: Immediately following laser treatment and daily for 1 week after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once consented, study participants will be randomized in a 1:1 ratio to one of two arms using a concealed permutated block randomization scheme to one of 2 arms - an experimental arm of BL laser treatment or a control arm of KTP laser treatment. Randomization sequence will be generated using a random number generator with randomly varying block sizes by the study statistician prior to the initiation of the study. Only the statistician and the research coordinator, who are not involved in the care of the patients, will know the randomization codes for allocation concealment. The intervention, i.e. type of laser used for treating the vocal fold lesions, is impossible to blind. Therefore this study is open-labeled. To further minimize bias from the open-labeled design, outcome measures will be collected and assessed by a blinded outcome assessor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Jun Lin, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513392
- Sponsor's protocol ID
- v1.0
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zeitels SM, Akst LM, Burns JA, Hillman RE, Broadhurst MS, Anderson RR. Office-based 532-nm pulsed KTP laser treatment of glottal papillomatosis and dysplasia. Ann Otol Rhinol Laryngol. 2006 Sep;115(9):679-85. doi: 10.1177/000348940611500905.
PubMed 17044539Hess MM, Fleischer S, Ernstberger M. New 445 nm blue laser for laryngeal surgery combines photoangiolytic and cutting properties. Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1557-1567. doi: 10.1007/s00405-018-4974-8. Epub 2018 Apr 19.
PubMed 29675755Lin RJ, Iakovlev V, Streutker C, Lee D, Al-Ali M, Anderson J. Blue Light Laser Results in Less Vocal Fold Scarring Compared to KTP Laser in Normal Rat Vocal Folds. Laryngoscope. 2021 Apr;131(4):853-858. doi: 10.1002/lary.28892. Epub 2020 Aug 4.
PubMed 32750168
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Outcome of Blue Light Laser and KTP Laser for Benign Vocal Fold Lesions: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04513392
- Acronym / sponsor ID
- v1.0
- Conditions
- Voice Disorders, RRP
- Keywords
- KTP, Blue light laser, laryngology, in office procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 14 Aug 2020 (actual)
- 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.
Preliminary investigations suggest that a novel blue light (BL) laser with a wavelength of 445nm is comparable to the commonly utilized KTP laser (532nm) for treatment of laryngeal pathologies. An animal study by the Principal Investigators showed that the blue light laser results in significantly less vocal fold scarring compared to the KTP laser, suggesting that the blue light laser may be a better instrument for treating vocal fold disease. However, there are no clinical studies directly comparing the two lasers on treatment of vocal fold pathology. The goal of the proposed study is to directly compare treatment outcomes of the BL laser and KTP laser for benign vocal fold lesions. All laser treatments will be performed in the office under local anesthesia as per standard of care. Outcome variables of interest will be compared between groups, including Voice Handicap Index-10 (VHI-10) score (measured at baseline, 1 week, 1 month, and 3 months post procedure), laryngeal stroboscopic findings (1 and 3 months post procedure), and intra-operative pain. This study will provide support that the blue light laser is a comparable alternative to the KTP laser and allow the addition of this novel laser to the armamentarium for treating vocal fold diseases.
Detailed description
A novel blue light (BL) laser, TruBlue surgical laser, has recently been approved by Health Canada for use in the larynx. It has a wavelength of 445nm, which is within the same visible light spectrum as the KTP laser (532nm). It is a photoangiolytic laser like the KTP and can be delivered through a flexible fiber and therefore allowing the procedure to be performed in clinic under local anesthesia. Other advantages include better tissue cutting and increased portability. No clinical studies in the literature have directly compared the BL laser and KTP laser in the treatment of benign vocal fold lesions. The main objective of this proposal is to compare between-group differences in patient perception of voice handicap between BL laser and KTP laser for treatment of benign vocal fold lesions at 3 months compared to baseline. Given the PIs' previous work comparing vocal fold scarring induced by these two lasers in a rat model, we hypothesize that the blue light laser will be equally effective at treating benign vocal fold lesions as the KTP laser, resulting in improved VHI-10 score at 3 months post laser treatment compared to baseline.
The KTP laser has been a workhorse laser used in Otolaryngology/Laryngology for awake treatments of vocal fold lesions. However, it is phasing out of the market as the laser itself as well as the laser fibers compatible with this laser are no longer being manufactured. Therefore, Laryngologists are eagerly looking for an alternative to the KTP laser in order to fill this gap in care. The BL laser is cheaper in costs and more portable compared to the KTP. It also has better tissue cutting abilities which can be useful in treating certain vocal fold lesions such as vocal fold cancer and subglottic stenosis. This study is the first to directly compare treatment outcomes between the BL laser and KTP laser for vocal fold lesions. If the BL laser is shown to be comparable to the KTP in this clinical study, it lends support that this novel laser is indeed an excellent alternative to the KTP laser and can therefore be incorporated into routine patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Once consented, study participants will be randomized in a 1:1 ratio to one of two arms using a concealed permutated block randomization scheme to one of 2 arms - an experimental arm of BL laser treatment or a control arm of KTP laser treatment. Randomization sequence will be generated using a random number generator with randomly varying block sizes by the study statistician prior to the initiation of the study. Only the statistician and the research coordinator, who are not involved in the care of the patients, will know the randomization codes for allocation concealment. The intervention, i.e. type of laser used for treating the vocal fold lesions, is impossible to blind. Therefore this study is open-labeled. To further minimize bias from the open-labeled design, outcome measures will be collected and assessed by a blinded outcome assessor.
| Arm | Type | Receives |
|---|---|---|
| KTP laser treatment | Active comparator | Procedure: Laser treatmentAll participants will complete a paper Voice Handicap Index-10 (VHI-10) questionnaire and laryngeal stroboscopy examination at baseline. Local anesthesia will be administered as per standard of care for in-office laryngeal procedures. KTP laser will be utilized to ablate the lesion of interest. Immediately following the procedure, participants will complete a VAS pain scale on paper. Participants will be asked to exercise 3 days of absolute voice rest following the procedure. All patients will have follow-up clinic appointments on POD 7, POD 30, and POD 90 after surgery. At each of the follow-up visit, the patients will fill out a paper VHI-10 questionnaire and undergo stroboscopic examination to assess vocal fold vibratory properties and closure, as well as residual lesions. During the first week post procedure, the participants will continue to complete a daily VAS at home for pain assessment. |
| BL laser treatment | Experimental | Procedure: Laser treatmentThe only difference in study procedures between the experimental arm and the control arm is that the experimental arm will use the BL laser. The post-operative instructions and follow-up schedule are identical. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Male and female, aged ≥ 18 years; and
- Diagnosed with benign vocal fold lesions such as papillomas and polyps and who are candidates for elective in office laser treatment for these lesions.
Key exclusion criteria (5 listed)
- < 18 years old;
- Current smokers;
- Vocal fold lesions such as vocal fold leukoplakia and vocal fold cancer;
- Systemic steroid use; and
- History of systemic illness that can affect wound healing.
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 |
|---|---|---|
| Laser treatmentA flexible laser fiber will be utilized via a channelled laryngoscope to ablate the benign laryngeal lesions as per standard of care. | Procedure or surgery | BL laser treatment, KTP laser treatment |
Primary outcome
Voice Handicap Index-10 (VHI-10)
Time frame: Change in VHI-10 score at 3 months
VHI-10 is a validated 10-item questionnaire that quantifies the impact of voice limitations on the individual's overall daily function. It has a Cronbach's alpha of 0.90, indicating high internal consistency. It ranges from a score of 0 to 40. The higher the score, the worse the patient's perception of voice handicap. A score of ≥11 is abnormal. It is a standard of care at the Laryngology outpatient clinic at St. Michael's Hospital for patients to fill out the VHI-10 on paper independently before each clinic visit.
2 secondary outcomes
Laryngeal stroboscopy
Time frame: 3 months post op compared with baseline
VAS pain scale
Time frame: Immediately following laser treatment and daily for 1 week after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Results publication: PubMed 17044539Zeitels SM, Akst LM, Burns JA, Hillman RE, Broadhurst MS, Anderson RR. Office-based 532-nm pulsed KTP laser treatment of glottal papillomatosis and dysplasia. Ann Otol Rhinol Laryngol. 2006 Sep;115(9):679-85. doi: 10.1177/000348940611500905.
- Results publication: PubMed 29675755Hess MM, Fleischer S, Ernstberger M. New 445 nm blue laser for laryngeal surgery combines photoangiolytic and cutting properties. Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1557-1567. doi: 10.1007/s00405-018-4974-8. Epub 2018 Apr 19.
- Results publication: PubMed 32750168Lin RJ, Iakovlev V, Streutker C, Lee D, Al-Ali M, Anderson J. Blue Light Laser Results in Less Vocal Fold Scarring Compared to KTP Laser in Normal Rat Vocal Folds. Laryngoscope. 2021 Apr;131(4):853-858. doi: 10.1002/lary.28892. Epub 2020 Aug 4.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Voice Disorders and RRP, run by University of Toronto.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R. Jun Lin, MD (416-864-5279, jrlin13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap Index-10 (VHI-10) (time frame: Change in VHI-10 score at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04513392, which also lists 3 linked publications.
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 14 Aug 2020.