Vocal Fold PolypNCT03046706
The Role of Vocal Rest After Removal of Benign Lesions From Vocal Cord
A study testing post operative voice rest and No voice rest in people with Vocal Fold Polyp and Vocal Cord Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The accepted recommendation after removal of vocal cord lesion is voice rest.This recommendation leads to great tension among the patients, loss of working days and need to practice speech therapy.The investigators hypothesize that voice rest after surgery does not affect the quality of the patient's voice. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Vocal Fold Polyp, Vocal Cord Dysfunction
- What is being tested?
- post operative voice rest and No voice rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jun 2017to 1 Feb 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Over 18 years old suffers a benign vocal cord lesion and candidate for surgical removal . Recruitment will take place in the voice and Swallowing Clinic. Rambam medical center. Israel.
Who cannot join
- A patient under 18.
- Demented patient.
- Deaf patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Voice Rest Contributes to the Quality of Voice After Surgery to Remove Benign Vocal Cord Lesion?
The accepted recommendation after removal of vocal cord lesion is voice rest.This recommendation leads to great tension among the patients, loss of working days and need to practice speech therapy.The investigators hypothesize that voice rest after surgery does not affect the quality of the patient's voice. The investigators will divide the patients into 2 groups: the first group will be instructed for a postoperative voice rest and the second group will not. Later the investigators will compare the results and conclude whether voice rest had any significance.
Read the detailed description
The prevailing view among laryngologists is that voice rest after laryngeal surgery is important to ensure a good recovery of the epithelium and lamina propria layers of the vocal cord. Speaking immediately after surgery leads to the formation of an irregular collagen in large quantities of the vocal cords - namely the creation scar tissue. The scarred vocal cords leads to a decrease in its elasticity, which is reflected in poor speech quality. Although this theory, not many works were published in the literature proving the necessity for voice rest after vocal cord surgery.
Several studies have been recently published which claim that there is no need for vocal rest and stress the importance of a moderate voice effort straight after surgery. This need is based on the idea that early mobilization of tissue after surgery led to the creation of a healthy soft tissue architecture.
The investigators hypothesize that there is no role for vocal rest after surgery to remove benign lesions from the vocal cords.
Patients candidate for laryngeal surgery that include removal of a benign vocal cord lesion will be divided into two groups:
- Patients instructed for the conventional post operative voice rest, namely absolute voice rest for a week and another week of relative voice rest (speaking is allowed for 20 minutes a day).
- Patients instructed to speak freely without restrictions after the surgery. those are the study phases: * first visit- preoperative visit.
- First the investigators prove by fiber optic examination that the patient suffers from the scourge of benign vocal cord lesion. Then the patient gets an explanation of the study, fill a demographic questionnaire. Next the patient fills the VHI (voice handicap index) questionnaire - a questionnaire which assesses the impact of the patient voice by 3 measures:emotional,functional and psychosocial. The questionnaire contains 30 questions. Any question dotted between 0-4 by the patient so that a higher score means more bad sound.
- Optical fiber testing is performed. Vocal cords including the lesion are photographed and video files are saved . Stroboscopic test for determining the quality of vibration, movement and closure of the vocal cords.The patient voice is recorded for future determination of the GRBAS (Grade,Roughness, breathiness, asthenia,strain). this index, scored by the laryngologists assesses the patient's voice according to five factors- grade, roughness, breathiness, asthenia,strain. Each parameter dotted between 0-3 so a higher score means more bad sound.The last test is objective. The voice recording will undergo computer analysis which determine the following voice objectives : fundamental frequency, jitter, shimmer, harmonic to noise ratio.
Lastly the patient is randomized (by block randomization) to determine to which group the patient belongs.
Patients belonging to the control group (standard post operative voice rest) receive a form where they annotate every day whether they kept on the instructed sound regime. This log will allow the investigators to track the compliance of the patients belonging to the voice rest group.
- Second visit- 3 days post operative
- Execute an optical fiber examination for description and evaluation of the recovery process of the vocal cord.
- Vocal cords including the lesion will be photographed and video files are saved. stroboscopic test for future determination of the quality of vibration, movement and closure of the vocal cods.
- Third visit- 14 days post operative
Same examination as the second visit are performed plus:
- The patient voice will be recorded to determine the GRBAS Index by the laryngologist. recording of the patient's voice for an objective voice analysis evaluation using a computer.
- Forth visit- 1 months post operative. Same examinations as the second visit are performed.
- Fifth visit- 3 months post operative. Same examinations as the second visit are performed plus patient fills VHI questionnaire.
- Sixth visit- 6 months post operative. Same examinations as the fifth visit are performed.
- Conditions
- Vocal Fold Polyp, Vocal Cord Dysfunction
- Being tested
- post operative voice rest, No voice rest
- Keywords
- voice rest, laryngeal surgery, glottic polyp, glottic cyst
- Medical subject headings
- Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post operative voice restBehavioural
After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day.
No voice restBehavioural
No limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions
| Study group | Role | What they receive |
|---|---|---|
| standard voice rest | Active comparator | This group maintains postoperative voice rest. Namely, absolute voice rest for a week, followed by a week of relative voice rest sound (talking is allowed for 20 minutes a day). post operative voice rest Receives: Behavioral: post operative voice rest |
| no voice rest | Experimental | This group has no limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions. Receives: Behavioral: No voice rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's evaluation of his own voice
VHI questionnaire score
Measured: 1 month post operative
Patient's evaluation of his own voice
VHI questionnaire score
Measured: 3 months post operative
Patient's evaluation of his own voice
VHI questionnaire score
Measured: 6 months post operative
doctors evaluation of the patient's voice
GRABS scale score
Measured: 1 month post operative
doctors evaluation of the patient's voice
GRABS scale score
Measured: 3 month post operative
doctors evaluation of the patient's voice
GRABS scale score
Measured: 6 month post operative
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
Measured: 1 month post operative
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
Measured: 3 month ost operative
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
Measured: 6 month post operative
Secondary outcomes (5)
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit:
- edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Measured: 3 days post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit:
- edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Measured: 2 weeks post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit:
- edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Measured: 1 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit:
- edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Measured: 3 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit:
- edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Measured: 6 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start20 Jun 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vocal Fold PolypStudies of the same condition, open and under way.
- 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
- The research group is the group of patients who do not keep voice rest and talk without restrictions or special instructions after surgery.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ziv gil, MD, Study director, Head of ear nose throat department Rambam medical center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046706
- Sponsor's protocol ID
- M.P
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2017
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Behrman A, Sulica L. Voice rest after microlaryngoscopy: current opinion and practice. Laryngoscope. 2003 Dec;113(12):2182-6. doi: 10.1097/00005537-200312000-00026.
PubMed 14660924Ishikawa K, Thibeault S. Voice rest versus exercise: a review of the literature. J Voice. 2010 Jul;24(4):379-87. doi: 10.1016/j.jvoice.2008.10.011. Epub 2009 Aug 5.
PubMed 19660903Kiagiadaki D, Remacle M, Lawson G, Bachy V, Van der Vorst S. The effect of voice rest on the outcome of phonosurgery for benign laryngeal lesions: preliminary results of a prospective randomized study. Ann Otol Rhinol Laryngol. 2015 May;124(5):407-12. doi: 10.1177/0003489414560583. Epub 2014 Nov 20.
PubMed 25416241Rousseau B, Gutmann ML, Mau T, Francis DO, Johnson JP, Novaleski CK, Vinson KN, Garrett CG. Randomized controlled trial of supplemental augmentative and alternative communication versus voice rest alone after phonomicrosurgery. Otolaryngol Head Neck Surg. 2015 Mar;152(3):494-500. doi: 10.1177/0194599814566601. Epub 2015 Jan 20.
PubMed 25605690Kaneko M, Shiromoto O, Fujiu-Kurachi M, Kishimoto Y, Tateya I, Hirano S. Optimal Duration for Voice Rest After Vocal Fold Surgery: Randomized Controlled Clinical Study. J Voice. 2017 Jan;31(1):97-103. doi: 10.1016/j.jvoice.2016.02.009. Epub 2016 Aug 1.
PubMed 27492336J. A. Koufman, P.D Blalock. Is voice rest never indicated? J. voice Vol 3, No. 1 87-91
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Voice Rest Contributes to the Quality of Voice After Surgery to Remove Benign Vocal Cord Lesion?
- ClinicalTrials.gov ID
- NCT03046706
- Acronym / sponsor ID
- M.P
- Conditions
- Vocal Fold Polyp, Vocal Cord Dysfunction
- Keywords
- voice rest, laryngeal surgery, glottic polyp, glottic cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 8 Feb 2017 (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.
The accepted recommendation after removal of vocal cord lesion is voice rest.This recommendation leads to great tension among the patients, loss of working days and need to practice speech therapy.The investigators hypothesize that voice rest after surgery does not affect the quality of the patient's voice. The investigators will divide the patients into 2 groups: the first group will be instructed for a postoperative voice rest and the second group will not. Later the investigators will compare the results and conclude whether voice rest had any significance.
Detailed description
The prevailing view among laryngologists is that voice rest after laryngeal surgery is important to ensure a good recovery of the epithelium and lamina propria layers of the vocal cord. Speaking immediately after surgery leads to the formation of an irregular collagen in large quantities of the vocal cords - namely the creation scar tissue. The scarred vocal cords leads to a decrease in its elasticity, which is reflected in poor speech quality. Although this theory, not many works were published in the literature proving the necessity for voice rest after vocal cord surgery.
Several studies have been recently published which claim that there is no need for vocal rest and stress the importance of a moderate voice effort straight after surgery. This need is based on the idea that early mobilization of tissue after surgery led to the creation of a healthy soft tissue architecture.
The investigators hypothesize that there is no role for vocal rest after surgery to remove benign lesions from the vocal cords.
Patients candidate for laryngeal surgery that include removal of a benign vocal cord lesion will be divided into two groups:
- Patients instructed for the conventional post operative voice rest, namely absolute voice rest for a week and another week of relative voice rest (speaking is allowed for 20 minutes a day).
- Patients instructed to speak freely without restrictions after the surgery. those are the study phases: * first visit- preoperative visit.
- First the investigators prove by fiber optic examination that the patient suffers from the scourge of benign vocal cord lesion. Then the patient gets an explanation of the study, fill a demographic questionnaire. Next the patient fills the VHI (voice handicap index) questionnaire - a questionnaire which assesses the impact of the patient voice by 3 measures:emotional,functional and psychosocial. The questionnaire contains 30 questions. Any question dotted between 0-4 by the patient so that a higher score means more bad sound.
- Optical fiber testing is performed. Vocal cords including the lesion are photographed and video files are saved . Stroboscopic test for determining the quality of vibration, movement and closure of the vocal cords.The patient voice is recorded for future determination of the GRBAS (Grade,Roughness, breathiness, asthenia,strain). this index, scored by the laryngologists assesses the patient's voice according to five factors- grade, roughness, breathiness, asthenia,strain. Each parameter dotted between 0-3 so a higher score means more bad sound.The last test is objective. The voice recording will undergo computer analysis which determine the following voice objectives : fundamental frequency, jitter, shimmer, harmonic to noise ratio.
Lastly the patient is randomized (by block randomization) to determine to which group the patient belongs.
Patients belonging to the control group (standard post operative voice rest) receive a form where they annotate every day whether they kept on the instructed sound regime. This log will allow the investigators to track the compliance of the patients belonging to the voice rest group.
- Second visit- 3 days post operative
- Execute an optical fiber examination for description and evaluation of the recovery process of the vocal cord.
- Vocal cords including the lesion will be photographed and video files are saved. stroboscopic test for future determination of the quality of vibration, movement and closure of the vocal cods.
- Third visit- 14 days post operative
Same examination as the second visit are performed plus:
- The patient voice will be recorded to determine the GRBAS Index by the laryngologist. recording of the patient's voice for an objective voice analysis evaluation using a computer.
- Forth visit- 1 months post operative. Same examinations as the second visit are performed.
- Fifth visit- 3 months post operative. Same examinations as the second visit are performed plus patient fills VHI questionnaire.
- Sixth visit- 6 months post operative. Same examinations as the fifth visit are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research group is the group of patients who do not keep voice rest and talk without restrictions or special instructions after surgery.
| Arm | Type | Receives |
|---|---|---|
| standard voice rest | Active comparator | Behavioral: post operative voice restThis group maintains postoperative voice rest. Namely, absolute voice rest for a week, followed by a week of relative voice rest sound (talking is allowed for 20 minutes a day). post operative voice rest |
| no voice rest | Experimental | Behavioral: No voice restThis group has no limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient Over 18 years old suffers a benign vocal cord lesion and candidate for surgical removal . Recruitment will take place in the voice and Swallowing Clinic. Rambam medical center. Israel.
Key exclusion criteria (3 listed)
- A patient under 18.
- Demented patient.
- Deaf patient.
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 |
|---|---|---|
| post operative voice restAfter surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day. | Behavioural | standard voice rest |
| No voice restNo limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions | Behavioural | no voice rest |
Primary outcome
Patient's evaluation of his own voice
Time frame: 1 month post operative
VHI questionnaire score
Patient's evaluation of his own voice
Time frame: 3 months post operative
VHI questionnaire score
Patient's evaluation of his own voice
Time frame: 6 months post operative
VHI questionnaire score
doctors evaluation of the patient's voice
Time frame: 1 month post operative
GRABS scale score
doctors evaluation of the patient's voice
Time frame: 3 month post operative
GRABS scale score
doctors evaluation of the patient's voice
Time frame: 6 month post operative
GRABS scale score
voice analysis by a software
Time frame: 1 month post operative
jitter score, shrimmer score, harmonic to noise ration
voice analysis by a software
Time frame: 3 month ost operative
jitter score, shrimmer score, harmonic to noise ration
voice analysis by a software
Time frame: 6 month post operative
jitter score, shrimmer score, harmonic to noise ration
5 secondary outcomes
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
Time frame: 3 days post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
Time frame: 2 weeks post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
Time frame: 1 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
Time frame: 3 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
Time frame: 6 month post operative
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 12 Mar 2020.
- Background: PubMed 14660924Behrman A, Sulica L. Voice rest after microlaryngoscopy: current opinion and practice. Laryngoscope. 2003 Dec;113(12):2182-6. doi: 10.1097/00005537-200312000-00026.
- Background: PubMed 19660903Ishikawa K, Thibeault S. Voice rest versus exercise: a review of the literature. J Voice. 2010 Jul;24(4):379-87. doi: 10.1016/j.jvoice.2008.10.011. Epub 2009 Aug 5.
- Background: PubMed 25416241Kiagiadaki D, Remacle M, Lawson G, Bachy V, Van der Vorst S. The effect of voice rest on the outcome of phonosurgery for benign laryngeal lesions: preliminary results of a prospective randomized study. Ann Otol Rhinol Laryngol. 2015 May;124(5):407-12. doi: 10.1177/0003489414560583. Epub 2014 Nov 20.
- Background: PubMed 25605690Rousseau B, Gutmann ML, Mau T, Francis DO, Johnson JP, Novaleski CK, Vinson KN, Garrett CG. Randomized controlled trial of supplemental augmentative and alternative communication versus voice rest alone after phonomicrosurgery. Otolaryngol Head Neck Surg. 2015 Mar;152(3):494-500. doi: 10.1177/0194599814566601. Epub 2015 Jan 20.
- Background: PubMed 27492336Kaneko M, Shiromoto O, Fujiu-Kurachi M, Kishimoto Y, Tateya I, Hirano S. Optimal Duration for Voice Rest After Vocal Fold Surgery: Randomized Controlled Clinical Study. J Voice. 2017 Jan;31(1):97-103. doi: 10.1016/j.jvoice.2016.02.009. Epub 2016 Aug 1.
- BackgroundJ. A. Koufman, P.D Blalock. Is voice rest never indicated? J. voice Vol 3, No. 1 87-91
- 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.
ziv gil, MD study director
Head of ear nose throat department Rambam medical center Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post operative voice rest and No voice rest in people with Vocal Fold Polyp and Vocal Cord Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 3 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Patient's evaluation of his own voice (time frame: 1 month post operative). The study lists 9 primary outcomes in all. 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 NCT03046706, which also lists 6 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 12 Mar 2020.