NCT04734483

Brief Summary

To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

December 3, 2020

Last Update Submit

January 29, 2021

Conditions

Larynx DiseaseLaryngeal Stenosis

Keywords

laryngeal stenosislaryngeal MRIlaryngeal CTpulmonary testlaryngoscopy

Outcome Measures

Primary Outcomes (4)

  • Change from baseline forced expiratory volume

    Spirometry

    at baseline and at 24-week postrandomization

  • Change from baseline area between vocal cords

    MRI and CT of larynx

    at baseline and at 24-week postrandomization

  • Change from basiline vocal fold vibration

    Laryngoscopy and stroboscopy

    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

    at baseline

Study Arms (4)

functional findings

ACTIVE COMPARATOR

Participants with laryngeal stenosis

Diagnostic Test: spirometry

to find anatomic feathers of larynx

ACTIVE COMPARATOR

Participants with laryngeal stenosis

Radiation: MRI and CTOther: Laryngoscopy

to determine the type of stenosis of larynx and method of surgical treatment

ACTIVE COMPARATOR

Participants with laryngeal stenosis

Diagnostic Test: spirometryRadiation: MRI and CTOther: LaryngoscopyOther: electromyography

determining the motor abilities of the muscles of the larynx

ACTIVE COMPARATOR

Participants with laryngeal stenosis

Other: electromyography

Interventions

spirometryDIAGNOSTIC_TEST

spirometry

functional findingsto determine the type of stenosis of larynx and method of surgical treatment
MRI and CTRADIATION

MRI and CT

to determine the type of stenosis of larynx and method of surgical treatmentto find anatomic feathers of larynx
LaryngoscopyOTHER

laryngoscopy

to determine the type of stenosis of larynx and method of surgical treatmentto find anatomic feathers of larynx
electromyographyOTHER

electromyography

determining the motor abilities of the muscles of the larynxto determine the type of stenosis of larynx and method of surgical treatment

Eligibility Criteria

Age1 Year - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • medically diagnosed with stenosis of larynx
  • patients who were observed larynx by MRI and CT
  • patients who need surgical treatment of stenosis of larynx

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Astana Medical University

Astana, 010000, Kazakhstan

RECRUITING

Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech

Saint Petersburg, 190013, Russia

RECRUITING

MeSH Terms

Conditions

Laryngeal DiseasesLaryngostenosis

Interventions

SpirometryMagnetic Resonance SpectroscopyLaryngoscopyNeurofeedback

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesRespiratory System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresBiofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Aliya Turayeva, PhD

    Astana Medical Academy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliya Turayeva, PhD

CONTACT

+77073681054cvetalnur@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment, prospective, single-center
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

February 2, 2021

Study Start

May 1, 2019

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

KA(1)RU(1)