Pleural DiseasesNCT06744725
Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial
A study testing Pleural biopsy using dual-function semirigid thoracoscopy and Pleural biopsy using semirigid thoracoscopy in people with Pleural Diseases, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
We designed and developed a novel dual-function semirigid thoracoscope (UE FET-680; UE Corporation, Zhejiang, China) with a straight channel adapted to flexible and rigid forceps for pleural 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?
- Pleural biopsy using dual-function semirigid thoracoscopy and Pleural biopsy using semirigid thoracoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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
- Age ≥ 18 years
- Unilateral pleural effusion of unclear etiology after a less invasive diagnosis
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed an informed consent form.
Who cannot join
- PaO2/FiO2 < 300
- Tendency for uncontrolled bleeding, unstable cardiovascular status, or severe heart failure
- A complete pleural symphysis, where it is not possible to create a pneumothorax
- Refractory cough
- Eastern Cooperative Oncology Group performance status 4
- Disagreements regarding study participation
- Participation in other studies within three months without withdrawal or termination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, MD,PhD, +86 18801336854, isdeng1017@163.com
About this study
Official title: Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Protocol for a Multicenter Open-label Randomized Controlled Trial
We designed and developed a novel dual-function semirigid thoracoscope (UE FET-680; UE Corporation, Zhejiang, China) with a straight channel adapted to flexible and rigid forceps for pleural biopsy. Our preclinical trial has proven that the dual-function semirigid thoracoscope has larger and deeper sampling while retaining the entire thoracic accessibility and flexible bronchoscopic maneuvering habits of the semirigid thoracoscope. We designed this study to directly compare the diagnostic yield, quality of sampling, and safety between the dual-function semirigid thoracoscope and semirigid thoracoscope.
- Conditions
- Pleural Diseases
- Being tested
- Pleural biopsy using dual-function semirigid thoracoscopy, Pleural biopsy using semirigid thoracoscopy
- Medical subject headings
- Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural biopsy using dual-function semirigid thoracoscopyDevice
Patients will receive pleural biopsy using dual-function semirigid thoracoscopy.
Pleural biopsy using semirigid thoracoscopyDevice
Patients received pleural biopsy using semirigid thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| Dual-function semirigid thoracoscopy | Experimental | Patients received pleural biopsy using dual-function semirigid thoracoscopy. Receives: Device: Pleural biopsy using dual-function semirigid thoracoscopy |
| Semirigid thoracoscopy | Experimental | Patients received pleural biopsy using semirigid thoracoscopy Receives: Device: Pleural biopsy using semirigid thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The diagnostic yield in this study was defined as the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744725
- Sponsor's protocol ID
- 2024-UE-1
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee P, Colt HG. Rigid and semirigid pleuroscopy: the future is bright. Respirology. 2005 Sep;10(4):418-25. doi: 10.1111/j.1440-1843.2005.00737.x.
PubMed 16135163Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.
PubMed 23418922Agarwal R, Aggarwal AN, Gupta D. Diagnostic accuracy and safety of semirigid thoracoscopy in exudative pleural effusions: a meta-analysis. Chest. 2013 Dec;144(6):1857-1867. doi: 10.1378/chest.13-1187.
PubMed 23928984Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. doi: 10.1378/chest.91.6.817.
PubMed 3581930Venekamp LN, Velkeniers B, Noppen M. Does 'idiopathic pleuritis' exist? Natural history of non-specific pleuritis diagnosed after thoracoscopy. Respiration. 2005 Jan-Feb;72(1):74-8. doi: 10.1159/000083404.
PubMed 15753638Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.
PubMed 26350935Deng M, Liu X, Chen W, Wei S, Zheng Z, Liao L, Zhang Q, Li J, Tong R, Porcel JM, Wang T, Hou G. Dual-functIon Semi-rigid thoraCoscOpy Versus semi-rigid thoracoscopy for the diagnosis of plEuRal diseases: protocol for a multicentre, open-label, randomised controlled trial in China (DISCOVER-I). Respir Res. 2026 Feb 9;27(1):129. doi: 10.1186/s12931-026-03554-0.
PubMed 41656194
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Protocol for a Multicenter Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06744725
- Acronym / sponsor ID
- 2024-UE-1
- Conditions
- Pleural Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 20 Dec 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.
We designed and developed a novel dual-function semirigid thoracoscope (UE FET-680; UE Corporation, Zhejiang, China) with a straight channel adapted to flexible and rigid forceps for pleural biopsy. Our preclinical trial has proven that the dual-function semirigid thoracoscope has larger and deeper sampling while retaining the entire thoracic accessibility and flexible bronchoscopic maneuvering habits of the semirigid thoracoscope. We designed this study to directly compare the diagnostic yield, quality of sampling, and safety between the dual-function semirigid thoracoscope and semirigid thoracoscope.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-function semirigid thoracoscopy | Experimental | Device: Pleural biopsy using dual-function semirigid thoracoscopyPatients received pleural biopsy using dual-function semirigid thoracoscopy. |
| Semirigid thoracoscopy | Experimental | Device: Pleural biopsy using semirigid thoracoscopyPatients received pleural biopsy using semirigid thoracoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Unilateral pleural effusion of unclear etiology after a less invasive diagnosis
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed an informed consent form.
Key exclusion criteria (7 listed)
- PaO2/FiO2 < 300
- Tendency for uncontrolled bleeding, unstable cardiovascular status, or severe heart failure
- A complete pleural symphysis, where it is not possible to create a pneumothorax
- Refractory cough
- Eastern Cooperative Oncology Group performance status 4
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 |
|---|---|---|
| Pleural biopsy using dual-function semirigid thoracoscopyPatients will receive pleural biopsy using dual-function semirigid thoracoscopy. | Device | Dual-function semirigid thoracoscopy |
| Pleural biopsy using semirigid thoracoscopyPatients received pleural biopsy using semirigid thoracoscopy | Device | Semirigid thoracoscopy |
Primary outcome
Diagnostic yield
Time frame: 6 Month
The diagnostic yield in this study was defined as the proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established.
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 20 Dec 2024.
- Results publication: PubMed 16135163Lee P, Colt HG. Rigid and semirigid pleuroscopy: the future is bright. Respirology. 2005 Sep;10(4):418-25. doi: 10.1111/j.1440-1843.2005.00737.x.
- Results publication: PubMed 23418922Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.
- Results publication: PubMed 23928984Agarwal R, Aggarwal AN, Gupta D. Diagnostic accuracy and safety of semirigid thoracoscopy in exudative pleural effusions: a meta-analysis. Chest. 2013 Dec;144(6):1857-1867. doi: 10.1378/chest.13-1187.
- Results publication: PubMed 3581930Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. doi: 10.1378/chest.91.6.817.
- Results publication: PubMed 15753638Venekamp LN, Velkeniers B, Noppen M. Does 'idiopathic pleuritis' exist? Natural history of non-specific pleuritis diagnosed after thoracoscopy. Respiration. 2005 Jan-Feb;72(1):74-8. doi: 10.1159/000083404.
- Results publication: PubMed 26350935Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available.
- Derived from this study: PubMed 41656194Deng M, Liu X, Chen W, Wei S, Zheng Z, Liao L, Zhang Q, Li J, Tong R, Porcel JM, Wang T, Hou G. Dual-functIon Semi-rigid thoraCoscOpy Versus semi-rigid thoracoscopy for the diagnosis of plEuRal diseases: protocol for a multicentre, open-label, randomised controlled trial in China (DISCOVER-I). Respir Res. 2026 Feb 9;27(1):129. doi: 10.1186/s12931-026-03554-0.
- Individual participant dataSharing planned: No
Related trials for Pleural Diseases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural biopsy using dual-function semirigid thoracoscopy and Pleural biopsy using semirigid thoracoscopy in people with Pleural Diseases, run by China-Japan Friendship Hospital at 1 site in China.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Dec 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 China. 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 Gang Hou, MD,PhD (010-84205729, hougangcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06744725, which also lists 7 linked publications.
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 20 Dec 2024.