NCT06161467

Brief Summary

To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy

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
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

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

September 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

September 19, 2023

Last Update Submit

December 5, 2023

Conditions

Ultrasound Therapy; Complications

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (2)

  • Vocal cords appearance

    Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)

    Two years

  • Vocal cords movement

    Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)

    Two years

Interventions

Ultrasound devicesDEVICE

Safe , no radiation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for thyroid surgery

You may qualify if:

  • Patients scheduled for thyroid surgery
  • Patients underwent thyroid surgery

You may not qualify if:

  • Patients with vocal cord paralysis because of any cause other than thyroid surgery complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.

    PMID: 19860577BACKGROUND

  • Holtel MR. Emerging technology in head and neck ultrasonography. Otolaryngol Clin North Am. 2010 Dec;43(6):1267-74, vii. doi: 10.1016/j.otc.2010.08.003.

    PMID: 21044741BACKGROUND

Study Officials

  • Amr Farouk, Professor

    Supervisor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wala Sayed, Student

CONTACT

01095876627walazidan898@gmail.com

Hasan Megaly, Professor

CONTACT

01006209584Hassnibrahim48@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2023

First Posted

December 8, 2023

Study Start

December 1, 2023

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

December 8, 2023

Record last verified: 2023-12