Pleural DiseasesNCT06226909
The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease
A study testing different types of ultrasound technique in people with Pleural Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases
- What is being tested?
- different types of ultrasound technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jan 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiographic evidence of pleural disease
Who cannot join
- Age < 18 y/o
- Patients who cannot hold their breath for 5 seconds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yao-Wen Kuo, kyw@ntu.edu.tw
About this study
Official title: The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease: a Randomized Controlled Trial
To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy.
- Conditions
- Pleural Diseases
- Being tested
- different types of ultrasound technique
- Medical subject headings
- Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different types of ultrasound techniqueProcedure or surgery
Shear-wave elastography-guided or B-mode ultrasound-guided
| Study group | Role | What they receive |
|---|---|---|
| Shear-wave elastography-guided | Experimental | based on the shear-wave elastography, the area with the highest elasticity value will be the target area to perform pleural biopsy for at least 6 times Receives: Procedure: different types of ultrasound technique |
| B-mode ultrasound-guided | Active comparator | based on the B-mode transthoracic ultrasound, the area with the maximal thickness will be the target area to perform pleural biopsy for at least 6 times Receives: Procedure: different types of ultrasound technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield of the two groups
the pathology of pleural biopsies will be interpreted by cytopathologists
Measured: 6 months
Secondary outcomes (2)
Procedure time
Procedure time
Measured: 1 day
the rate of pneumothorax & hemothorax
Safety
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start15 Jan 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Wen Kuo, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226909
- Sponsor's protocol ID
- 202311139RINC
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06226909
- Acronym / sponsor ID
- 202311139RINC
- Conditions
- Pleural Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Jan 2024 (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 investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shear-wave elastography-guided | Experimental | Procedure: different types of ultrasound techniquebased on the shear-wave elastography, the area with the highest elasticity value will be the target area to perform pleural biopsy for at least 6 times |
| B-mode ultrasound-guided | Active comparator | Procedure: different types of ultrasound techniquebased on the B-mode transthoracic ultrasound, the area with the maximal thickness will be the target area to perform pleural biopsy for at least 6 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with radiographic evidence of pleural disease
Key exclusion criteria (2 listed)
- Age < 18 y/o
- Patients who cannot hold their breath for 5 seconds
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 |
|---|---|---|
| different types of ultrasound techniqueShear-wave elastography-guided or B-mode ultrasound-guided | Procedure or surgery | B-mode ultrasound-guided, Shear-wave elastography-guided |
Primary outcome
The diagnostic yield of the two groups
Time frame: 6 months
the pathology of pleural biopsies will be interpreted by cytopathologists
2 secondary outcomes
Procedure time
Time frame: 1 day
the rate of pneumothorax & hemothorax
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Yao-Wen Kuo principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different types of ultrasound technique in people with Pleural Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao-Wen Kuo (0972651821, kyw@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic yield of the two groups (time frame: 6 months). 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 1 Feb 2024.