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New lung biopsy technique could spot TB faster and safer

NCT ID NCT07459569

Diagnosis Sponsor: China-Japan Friendship Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new biopsy method called EBUS-TBMC against the standard needle approach for diagnosing tuberculosis in chest lymph nodes. About 108 adults with suspected TB will undergo both procedures in one session to see which yields better tissue samples. The goal is to improve diagnostic accuracy and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) procedure
What this could lead to
If successful, this could lead to a more accurate and safer way to diagnose tuberculosis in lymph nodes, reducing the need for repeat procedures.
What could go wrong
This is a small, early-stage trial (108 participants) comparing two procedures. The new method may not prove significantly better or could carry higher bleeding risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older; * Presence of unexplained mediastinal lymphadenopathy (short-axis diameter ≥1 cm on chest computed tomography) with clinical suspicion of tuberculosis; * Completion of routine pre-procedural evaluations including blood tests (complete blood count, coagulation profile), electrocardiogram, and chest CT; * Absence of contraindications for EBUS-TBNA or EBUS-TBMC procedures; * Provision of written informed consent after being fully informed of the study purpose and procedures. Exclusion Criteria: * Known allergy to lidocaine or midazolam; * Presence of bronchial artery penetration into the target lesion or high risk of bleeding as detected by contrast-enhanced CT or EBUS Doppler mode prior to the procedure; * Unstable angina, congestive heart failure, or severe bronchial asthma; * Evidence of significant liquefaction necrosis in the target mediastinal lymph node on pre-procedural CT or EBUS; * Patient refusal to participate in the study; * Participation in another clinical trial within the past three months that may interfere with the outcomes of this study; * Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation

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Conditions

The condition(s) this trial relates to.

lymph node tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mediastinal and hilar lymph node enlargement Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 2nd Yinghuadong Street, Beijing, China

    Beijing, Beijing Municipality, 100029, China

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