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Disposable scope takes on gold standard in pleural diagnosis

NCT ID NCT07726784

Knowledge-focused Sponsor: National University of Malaysia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This pilot trial tests whether a single-use flexible bronchoscope can safely and effectively replace the semi-rigid pleuroscope for diagnosing pleural effusion—a buildup of fluid around the lungs. Hospitalized patients needing a tissue sample will be randomly assigned to one of the two devices. The study focuses on feasibility, including how often the procedure is completed successfully, and compares procedure time 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
single-use flexible bronchoscope
What this could lead to
If the disposable flexible scope proves as safe and effective as the standard tool, it could offer a cheaper, more accessible option for diagnosing pleural effusion.
What could go wrong
This is a small pilot study with only 36 participants, so results may not apply broadly. The flexible scope may be harder to use or provide poorer views than the standard device.

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 36 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 * Patient presents with an undifferentiated pleural effusion with or without initial diagnostic thoracocentesis, thereby necessitating definitive pleural tissue sampling. * Demonstrated presence of a visually significant pleural effusion occupying at least one-third of the affected hemithorax on standard chest radiography, or a visually confirmed loculated effusion accessible via thoracic ultrasound mapping. * The patient has demonstrated full willingness to participate and has signed the formal written informed consent form approved by the institutional review board. Exclusion Criteria: * Age \< 18 years * Patients with contraindications to perform medical thoracoscopy, e.g.: * Uncorrectable coagulopathy (e.g., platelet count \<50,000/µL, INR \>1.5 despite correction) * Severe hypoxemia not correctable with supplemental oxygen * Hemodynamic instability * Extensive pleural adhesions or obliterated pleural space on imaging * Uncontrolled cardiac arrhythmia or recent acute coronary syndrome * Severe pulmonary hypertension with high procedural risk * Inability to tolerate lateral decubitus position * Refusal to provide informed consent * Pregnancy * Previous ipsilateral pleurodesis or thoracic surgery significantly altering pleural anatomy

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Conditions

The condition(s) this trial relates to.

myeloproliferative disorder, chronic, with eosinophilia Pleural Effusion Pleural Effusion, Malignant

As listed by the trial registrant

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

Malignant pleural effusions (MPE) Medical thoracoscopy Pleural effusion

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

  • Hospital Canselor Tuanku Muhriz, National University of Malaysia,

    Cheras, Kuala Lumput, 56000, Malaysia

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