NCT03450694

Brief Summary

The aim of the study is to assess the efficiency and limitations of ultrasound in detecting and characterizing laryngeal anatomy and study of some laryngeal disorders and their ultrasonographic appearance.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

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

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 23, 2018

Last Update Submit

February 23, 2018

Conditions

Laryngeal Disease

Outcome Measures

Primary Outcomes (1)

  • role of ultrasound in diagnosis of laryngeal lesions

    statistical study will be done between ultrasound and laryngoscope to assess sensitivity, specificity and accuracy of ultrasound in detecting lesions, differentiate benign from malignant lesions and reach final diagnosis of the laryngeal lesions.

    baseline

Interventions

ultrasoundDEVICE

ultrasound is a non-invasive and not expensive method, availiable at almost all institutions.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients complaining of laryngeal lesions in adult adult age group between 18:65 years of both sexes. they are previously diagnosed by laryngoscope.

You may qualify if:

  • Patients complaining of laryngeal lesions in adult age group between age 18:65 years of both sexes.

You may not qualify if:

  • patients \< 18 years
  • patients \> 65 years
  • patients with spinal lesions who needs spinal immobilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Agrawal N, Ha PK. Management of early-stage laryngeal cancer. Otolaryngol Clin North Am. 2008 Aug;41(4):757-69, vi-vii. doi: 10.1016/j.otc.2008.01.014.

    PMID: 18570957BACKGROUND

  • 3. Arruti, A. and Poumayrac, D.M., 2010. Larynx ultrasonography: an alternative technique in the evaluation of the aero-digestive crossroad. Rev Imagenol, 14(1), pp.30-6.

    BACKGROUND

  • American Cancer Society, 2008. Cancer facts & figures. The Society.

    BACKGROUND

  • Arens C, Eistert B, Glanz H, Waas W. Endolaryngeal high-frequency ultrasound. Eur Arch Otorhinolaryngol. 1998;255(5):250-5. doi: 10.1007/s004050050052.

    PMID: 9638467BACKGROUND

  • Muscat JE, Liu HP, Livelsberger C, Richie JP Jr, Stellman SD. The nicotine dependence phenotype, time to first cigarette, and larynx cancer risk. Cancer Causes Control. 2012 Mar;23(3):497-503. doi: 10.1007/s10552-012-9909-x. Epub 2012 Feb 25.

    PMID: 22367700BACKGROUND

  • Shao J, Stern J, Wang ZM, Hanson D, Jiang J. Clinical evaluation of 70 degrees and 90 degrees laryngeal telescopes. Arch Otolaryngol Head Neck Surg. 2002 Aug;128(8):941-4. doi: 10.1001/archotol.128.8.941.

    PMID: 12162775BACKGROUND

  • Shau YW, Wang CL, Hsieh FJ, Hsiao TY. Noninvasive assessment of vocal fold mucosal wave velocity using color doppler imaging. Ultrasound Med Biol. 2001 Nov;27(11):1451-60. doi: 10.1016/s0301-5629(01)00453-7.

    PMID: 11750743BACKGROUND

  • Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14.

    PMID: 26667886BACKGROUND

  • 12. Wendy, D., 2007. Laryngeal ultrasound provides non invasive assessment of vocal fold lesions. Ann Otol Rhinol Laryngol, 171, pp.631-647.

    BACKGROUND

  • Wolf M, Primov-Fever A, Amir O, Jedwab D. The feasibility of rigid stroboscopy in children. Int J Pediatr Otorhinolaryngol. 2005 Aug;69(8):1077-9. doi: 10.1016/j.ijporl.2005.03.004. Epub 2005 Mar 31.

    PMID: 16005350BACKGROUND

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

menna samy, resident

CONTACT

+201098989868mennatallahsamy@yahoo.com

hossam galal, assistant professor

CONTACT

01014269335h.elmalah@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mennat-Allah Samy

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

March 1, 2018

Record last verified: 2018-02