Application of Transthoracic Shear-wave Ultrasound Elasto... | NCT04781894

Studies
Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions

NCT04781894

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Aug 20, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Elasticity Imaging Techniques

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2021Actual

Primary Completion Date

Jan 25, 2025Estimated

Completion Date

Jan 25, 2025Estimated

First Submitted Date

Mar 1, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Application of transthoracic shear-wave ultrasound elastography in pleural lesions	to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with radiographic evidence of pleural lesions or effusion

Exclusion Criteria:

Age < 20 y/o
Patients who cannot hold their breath for 5 seconds

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving chest ultrasonography in National Taiwan University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yao-Wen Kuo, MD	Contact	0972-651-821		kyw@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Yao-Wen Kuo, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan