ClinicalTrials.gg
Not yet recruitingNCT07040241Confocal laserUpdated Jun 27, 2025

Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy

An interventional study of Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy and Ultrasound-guided pleural biopsy in Pleural Effusion Disorder, sponsored by China-Japan Friendship Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.

02

Conditions studied

  • Pleural Effusion Disorder

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Keywords

  • Pleural effusion
  • Confocal laser endomicroscopy
  • Pleural biopsy
03

In context

Pleural Effusion

241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.

This study's planned enrollment of 260 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients with exudative pleural effusion of unknown origin
  • Patients with negative pleural fluid cytology results
  • Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation
  • Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an form

Exclusion criteria

Exclusion Criteria:

  • Inability or refusal to undergo UGBx
  • Patients with any for pleural
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    CLE-assisted ultrasound-guided pleural biopsy

    The patients in this arm will receive the CLE-assisted ultrasound-guided pleural biopsy

    Procedure: Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

  • Placebo comparator
    Ultrasound-guided pleural biopsy

    The patients in this arm will receive the ultrasound-guided pleural biopsy

    Procedure: Ultrasound-guided pleural biopsy

Interventions

  • ProcedureConfocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

    Using the probe-based confocal laser endomicroscopy to detect the pleural, and ensure the biopsy location. Then, use the pleural biopsy tool to complete the pleural biopsy. The whole procession will under the ultrasound guidance.

    Also known as: CLE-assisted ultrasound-guided pleural biopsy

  • ProcedureUltrasound-guided pleural biopsy

    Using ultrasound to detect the biopsy site and perform pleural biopsy.

06

What researchers measure

Primary outcomes

  1. Diagnostic yield

    The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.

    Time frame: The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2025; primary completion for Jul 2027, 24 months later.

Of 61 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 24 months is below that.

Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2025
First posted
Jun 27, 2025
StartEst.
Jul 1, 2025
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Jun 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07040241
Responsible party
Gang Hou (Deputy Director of the Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital) — Principal investigator
First posted
Jun 27, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jun 27, 2025

Study contacts

Mingming Deng, Doctor
Contact
isdeng1017@163.com
+86 18801336854

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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