Vocal Cord Paralysis UnilateralPhase 2VOCALISTNCT02973152
Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.
A Phase 2 study testing Thyroplasty and Reinnervation in people with Vocal Cord Paralysis Unilateral, run by Royal National Throat, Nose and Ear Hospital at 1 site in United Kingdom.
Trial summary
The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis. There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vocal Cord Paralysis Unilateral
- What is being tested?
- Thyroplasty and Reinnervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 30 Apr 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
- Age from 18 to 70 years old
- Male or female
- Able to provide informed consent
- A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score >16)
- Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side.
Who cannot join
- Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
- Severe lung disorders
- Structural vocal fold lesions such as polyp
- Previous laryngeal framework surgery
- Cricoarytenoid joint fixation (CAJF)
- Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
Show all 12Show fewer
- Previous Level 2, 3 or 4 thyroid neck dissection
- Previous ipsilateral surgical neck dissection
- Previous radiotherapy to the head and neck
- Laryngeal injection of a rapidly absorbable material in the last 6 months.
- Previous laryngeal injection of a non-rapidly absorbable material (e.g. bioplastics, VOX)
- Neuromuscular disease affecting the larynx or multiple cranial nerve palsies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road
London, WC1X 8DA
About this study
Official title: Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.
The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis.
There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.
Read the detailed description
Title: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study
Short title: VOCALIST
Trial medication: Not Applicable
Phase of trial: Phase IIb
Objectives: The aim of the study is to establish the feasibility of a multicentre, randomised phase III clinical trial of surgical treatment for Unilateral Vocal Fold Paralysis (UVFP).
Main objectives are to test the feasibility of:
- the multicentre recruitment process, including continuous improvement to the process based on qualitative analysis;
- recruiters being able to present true equipoise with the treatment arms;
- the randomisation process and investigate reasons for any difficulties that affect recruitment
- the utility of the following characteristics of the proposed primary (voice handicap index) and secondary outcomes: variability across patients, variability over time, differences in outcome between randomised groups over time;
- process of follow up visits and diary completion;
- means of gathering health economics and health-related quality of life data suitable for measuring cost effectiveness.
Type of trial: Quantitative and Qualitative Feasibility Study; multi-centre randomised controlled trial
Trial design and methods: 30 patients will be randomised to receive the Laryngeal Reinnervation or Type I Thyroplasty surgery.
Trial duration per participant: 12 months
Estimated total trial duration: 24 months
Planned trial sites: Multi-site; London, Poole and Manchester (3 sites).
Total number of participants planned: 30
Statistical methodology and analysis: The trial analysis will be descriptive and will be performed on an intention to treat basis. Primary and secondary outcomes will be described using proportions and means as appropriate, with confidence intervals. No formal comparisons will be made. The correlations between the voice outcome measures will be calculated. There is no planned interim analysis.
- Conditions
- Vocal Cord Paralysis Unilateral
- Being tested
- Thyroplasty, Reinnervation
- Keywords
- Type I Thyroplasty, Reinnervation
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroplastyProcedure or surgery
This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously.
ReinnervationProcedure or surgery
For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63).
| Study group | Role | What they receive |
|---|---|---|
| Thyroplasty | Active comparator | This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously. Receives: Procedure: Thyroplasty |
| Reinnervation | Active comparator | For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63). Receives: Procedure: Reinnervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the participant was randomised (yes/no)
From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)
Measured: 24 months
Whether the participant successfully received the allocated operation (yes/no)
From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)
Measured: 24 months
Whether the participant completed the trial (yes/no)
From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)
Measured: 24 months
Secondary outcomes (15)
Whether the Study Management Group (SMG) and recruiters are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews.
Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice.
Measured: 24 months
Whether surgeons and speech therapists are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews. between the two treatments
Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice.
Measured: 24 months
Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes
Assessed by a Qualitative researcher via interviews with patients will explore the acceptability of the trial interventions and trial processes and reasons for participation / non-participation (where applicable).
Measured: 24 months
Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures
Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice. Interviews with patients will explore the acceptability of the trial interventions and trial processes and reasons for participation / non-participation (where applicable).
Measured: 24 months
Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.
Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice.Interviews with patients will explore the acceptability of the trial interventions and trial processes and reasons for participation / non-participation (where applicable).
Measured: 24 months
The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
Perceptual voice quality analysis will be determined using the GRBAS scale.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
The OperaVOX™ system will also be used to perform the acoustic voice analysis.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
The validated 100ml Water Swallow test will be used to measure the participants' swallowing.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
Laryngeal EMG will be used to detect laryngeal muscle activity.
The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures.
Measured: Baseline, 6 months and 12 month post surgery
Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.
A detailed cost analysis of laryngeal reinnervation and thyroplasty procedures will be undertaken, since these are likely to be major cost components affecting the relative cost-effectiveness of laryngeal reinnervation. This will include the costs of the index procedure (staff costs, theatre costs, costs of consumables, recovery costs), length of hospital stay for index procedure, post-operative ibuprofen, and speech and language therapy. Costs for the index procedure will be obtained from the hospital finance department.
Measured: 24 months
Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.
An analysis of the feasibility study for a full economic evaluation of laryngeal reinnervation versus thyroplasty that will accompany the Phase III trial. This will be based on the idea that we will be aiming estimate the lifetime incremental cost per quality-adjusted life year (QALY) gained of laryngeal reinnervation versus thyroplasty, the outcome measure recommended by NICE when evaluating the cost-effectiveness of health care programmes in the NHS.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startMay 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord Paralysis UnilateralStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal National Throat, Nose and Ear Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Joint Research Office, University College London Hospitals, National Institute for Health Research, United Kingdom, Sealed Envelope: Redpill Online Application
- Responsible party
- Principal investigator, Professor Martin Birchall, Royal National Throat, Nose and Ear Hospital
- Investigators
- Professor Martin Birchall, FRCS,FMedSci, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973152
- Sponsor's protocol ID
- 11/0107
- Other IDs
- PB-PG-1013-32058
- Acronym
- VOCALIST
- Status last verified
- May 2018
- First submitted
- 3 Nov 2016
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.
- ClinicalTrials.gov ID
- NCT02973152
- Acronym / sponsor ID
- VOCALIST / 11/0107
- Conditions
- Vocal Cord Paralysis Unilateral
- Keywords
- Type I Thyroplasty, Reinnervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Royal National Throat, Nose and Ear HospitalUniversity, hospital or other
- Collaborators
- University College Joint Research Office, University College London Hospitals, National Institute for Health Research, United Kingdom, Sealed Envelope: Redpill Online Application
- Study start
- May 2016
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 25 Nov 2016 (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 purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis.
There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.
Detailed description
Title: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study
Short title: VOCALIST
Trial medication: Not Applicable
Phase of trial: Phase IIb
Objectives: The aim of the study is to establish the feasibility of a multicentre, randomised phase III clinical trial of surgical treatment for Unilateral Vocal Fold Paralysis (UVFP).
Main objectives are to test the feasibility of:
- the multicentre recruitment process, including continuous improvement to the process based on qualitative analysis;
- recruiters being able to present true equipoise with the treatment arms;
- the randomisation process and investigate reasons for any difficulties that affect recruitment
- the utility of the following characteristics of the proposed primary (voice handicap index) and secondary outcomes: variability across patients, variability over time, differences in outcome between randomised groups over time;
- process of follow up visits and diary completion;
- means of gathering health economics and health-related quality of life data suitable for measuring cost effectiveness.
Type of trial: Quantitative and Qualitative Feasibility Study; multi-centre randomised controlled trial
Trial design and methods: 30 patients will be randomised to receive the Laryngeal Reinnervation or Type I Thyroplasty surgery.
Trial duration per participant: 12 months
Estimated total trial duration: 24 months
Planned trial sites: Multi-site; London, Poole and Manchester (3 sites).
Total number of participants planned: 30
Statistical methodology and analysis: The trial analysis will be descriptive and will be performed on an intention to treat basis. Primary and secondary outcomes will be described using proportions and means as appropriate, with confidence intervals. No formal comparisons will be made. The correlations between the voice outcome measures will be calculated. There is no planned interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroplasty | Active comparator | Procedure: ThyroplastyThis medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously. |
| Reinnervation | Active comparator | Procedure: ReinnervationFor laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
- Age from 18 to 70 years old
- Male or female
- Able to provide informed consent
- A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score >16)
Key exclusion criteria (12 listed)
- Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
- Severe lung disorders
- Structural vocal fold lesions such as polyp
- Previous laryngeal framework surgery
- Cricoarytenoid joint fixation (CAJF)
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 |
|---|---|---|
| ThyroplastyThis medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously. | Procedure or surgery | Thyroplasty |
| ReinnervationFor laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63). | Procedure or surgery | Reinnervation |
Primary outcome
Whether the participant was randomised (yes/no)
Time frame: 24 months
From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)
Whether the participant successfully received the allocated operation (yes/no)
Time frame: 24 months
From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)
Whether the participant completed the trial (yes/no)
Time frame: 24 months
From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)
15 secondary outcomes
Whether the Study Management Group (SMG) and recruiters are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews.
Time frame: 24 months
Whether surgeons and speech therapists are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews. between the two treatments
Time frame: 24 months
Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes
Time frame: 24 months
Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures
Time frame: 24 months
Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.
Time frame: 24 months
The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life
Time frame: Baseline, 6 months and 12 month post surgery
The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.
Time frame: Baseline, 6 months and 12 month post surgery
The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.
Time frame: Baseline, 6 months and 12 month post surgery
The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.
Time frame: Baseline, 6 months and 12 month post surgery
Perceptual voice quality analysis will be determined using the GRBAS scale.
Time frame: Baseline, 6 months and 12 month post surgery
The OperaVOX™ system will also be used to perform the acoustic voice analysis.
Time frame: Baseline, 6 months and 12 month post surgery
The validated 100ml Water Swallow test will be used to measure the participants' swallowing.
Time frame: Baseline, 6 months and 12 month post surgery
Laryngeal EMG will be used to detect laryngeal muscle activity.
Time frame: Baseline, 6 months and 12 month post surgery
Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.
Time frame: 24 months
Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.
Time frame: 24 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 29 May 2018.
- 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.
Professor Martin Birchall, FRCS,FMedSci principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thyroplasty and Reinnervation in people with Vocal Cord Paralysis Unilateral, run by Royal National Throat, Nose and Ear Hospital at 1 site in United Kingdom.
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 6 inclusion and 12 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 29 May 2018. 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 United Kingdom. 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.
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?
Whether the participant was randomised (yes/no) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 29 May 2018.