Larynx DiseaseNCT04734483
The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis
A study testing spirometry, MRI and CT and Laryngoscopy in people with Larynx Disease and Laryngeal Stenosis, run by Astana Medical University at 2 sites in 2 countries.
Trial summary
To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment. Read more about this study
- Who is it for?
- Ages 1 year to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Larynx Disease, Laryngeal Stenosis
- What is being tested?
- spirometry, MRI and CT and Laryngoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2019to 1 Jun 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 1 year to 74 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- medically diagnosed with stenosis of larynx
- patients who were observed larynx by MRI and CT
- patients who need surgical treatment of stenosis of larynx
Who cannot join
- pregnancy
- patients who has positive electromyography findings of motion of laryngeal muscles
- patients who has contraindications to surgical treatment on the other diseases
- patients who has not normal results of lab. analyses
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kazakhstan1 site, 1 recruiting
- Recruiting
Astana Medical University
Astana, 010000
Rais Tulebaev, Professor, +77017104509, rais007@rambler.ru
Aliya Turayeva, PhD, +77073681054, cvetalnur@mail.ru
Russia1 site, 1 recruiting
- Recruiting
Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech
Saint Petersburg, 190013
Sergey Karpischenko, Prifessor, +7911717-62-26, karpischenkos@mail.ru
About this study
To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.
Read the detailed description
The study include patients with laryngeal pathology in the otorhinolaryngology clinic of the 1-city hospital at Nur-Sultan city. All patients cheek up the necessary clinical, functional, diagnostic studies and treatment measures. It is planned to examine and operate on 70 patients with laryngeal pathology.
- To study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries.
- To develop optimal diagnostic methods for patients with laryngeal stenosis.
- To assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis.
- To develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.
- Conditions
- Larynx Disease, Laryngeal Stenosis
- Being tested
- spirometry, MRI and CT, Laryngoscopy, electromyography
- Keywords
- laryngeal stenosis, laryngeal MRI, laryngeal CT, pulmonary test, laryngoscopy
- Medical subject headings
- Laryngeal Diseases, Laryngostenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
spirometry
MRI and CTRadiation
MRI and CT
LaryngoscopyOther
laryngoscopy
electromyographyOther
electromyography
| Study group | Role | What they receive |
|---|---|---|
| functional findings | Active comparator | Participants with laryngeal stenosis Receives: Diagnostic Test: spirometry |
| to find anatomic feathers of larynx | Active comparator | Participants with laryngeal stenosis Receives: Radiation: MRI and CT; Other: Laryngoscopy |
| to determine the type of stenosis of larynx and method of surgical treatment | Active comparator | Participants with laryngeal stenosis Receives: Diagnostic Test: spirometry; Radiation: MRI and CT; Other: Laryngoscopy; Other: electromyography |
| determining the motor abilities of the muscles of the larynx | Active comparator | Participants with laryngeal stenosis Receives: Other: electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline forced expiratory volume
Spirometry
Measured: at baseline and at 24-week postrandomization
Change from baseline area between vocal cords
MRI and CT of larynx
Measured: at baseline and at 24-week postrandomization
Change from basiline vocal fold vibration
Laryngoscopy and stroboscopy
Measured: at baseline and at 24-week postrandomization
Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.
Electromyography
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 May 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx DiseaseStudies 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
- Parallel Assignment, prospective, single-center
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aliya Turayeva, PhD, Principal investigator, Astana Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734483
- Sponsor's protocol ID
- Aliya_Turayeva
- Other IDs
- dr.turayeva
- Status last verified
- Jan 2021
- First submitted
- 3 Dec 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis
- ClinicalTrials.gov ID
- NCT04734483
- Acronym / sponsor ID
- Aliya_Turayeva
- Conditions
- Larynx Disease, Laryngeal Stenosis
- Keywords
- laryngeal stenosis, laryngeal MRI, laryngeal CT, pulmonary test, laryngoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 2 Feb 2021 (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.
To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.
Detailed description
The study include patients with laryngeal pathology in the otorhinolaryngology clinic of the 1-city hospital at Nur-Sultan city. All patients cheek up the necessary clinical, functional, diagnostic studies and treatment measures. It is planned to examine and operate on 70 patients with laryngeal pathology.
- To study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries.
- To develop optimal diagnostic methods for patients with laryngeal stenosis.
- To assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis.
- To develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment, prospective, single-center
| Arm | Type | Receives |
|---|---|---|
| functional findings | Active comparator | Diagnostic Test: spirometryParticipants with laryngeal stenosis |
| to find anatomic feathers of larynx | Active comparator | Radiation: MRI and CT, Other: LaryngoscopyParticipants with laryngeal stenosis |
| to determine the type of stenosis of larynx and method of surgical treatment | Active comparator | Diagnostic Test: spirometry, Radiation: MRI and CT, Other: Laryngoscopy, Other: electromyographyParticipants with laryngeal stenosis |
| determining the motor abilities of the muscles of the larynx | Active comparator | Other: electromyographyParticipants with laryngeal stenosis |
Who may qualify
- Ages
- 1 year to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- medically diagnosed with stenosis of larynx
- patients who were observed larynx by MRI and CT
- patients who need surgical treatment of stenosis of larynx
Key exclusion criteria (4 listed)
- pregnancy
- patients who has positive electromyography findings of motion of laryngeal muscles
- patients who has contraindications to surgical treatment on the other diseases
- patients who has not normal results of lab. analyses
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 |
|---|---|---|
| spirometryspirometry | Diagnostic test | functional findings, to determine the type of stenosis of larynx and method of surgical treatment |
| MRI and CTMRI and CT | Radiation | to determine the type of stenosis of larynx and method of surgical treatment, to find anatomic feathers of larynx |
| Laryngoscopylaryngoscopy | Other | to determine the type of stenosis of larynx and method of surgical treatment, to find anatomic feathers of larynx |
| electromyographyelectromyography | Other | determining the motor abilities of the muscles of the larynx, to determine the type of stenosis of larynx and method of surgical treatment |
Primary outcome
Change from baseline forced expiratory volume
Time frame: at baseline and at 24-week postrandomization
Spirometry
Change from baseline area between vocal cords
Time frame: at baseline and at 24-week postrandomization
MRI and CT of larynx
Change from basiline vocal fold vibration
Time frame: at baseline and at 24-week postrandomization
Laryngoscopy and stroboscopy
Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.
Time frame: at baseline
Electromyography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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.
Aliya Turayeva, PhD principal investigator
Astana Medical Academy
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spirometry, MRI and CT and Laryngoscopy in people with Larynx Disease and Laryngeal Stenosis, run by Astana Medical University at 2 sites in 2 countries.
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 3 inclusion and 4 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan, Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliya Turayeva, PhD (+77073681054, cvetalnur@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline forced expiratory volume (time frame: at baseline and at 24-week postrandomization). The study lists 4 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 2 Feb 2021.