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Surgical fix for failed lung valve treatment shows promise in early trial

NCT ID NCT07682168

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Jul 02, 2026

Summary

This trial investigates a surgical procedure to divide the fissure between lung lobes in people with COPD and emphysema who did not improve after endobronchial valve treatment. The goal is to see if the surgery is safe and feasible, potentially leading to better lung collapse and function. The study enrolls up to 15 patients and tracks success rates, complications, and costs.

What this could mean

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

Active substance
surgical division of the interlobar fissure
What this could lead to
If safe and effective, this procedure could offer a new option for COPD patients who do not respond to standard lung volume reduction treatments.
What could go wrong
This is a small early safety study with only 15 participants, so results may not apply broadly. The surgery carries risks like any thoracoscopic procedure, including infection or bleeding.

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 15 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 75 years

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 1. Age \< or equal 75 years 2. Stable COPD with less than or equal to 10mg prednisolone daily 3. Nonsmoking for 3 months prior to screening and willing to not smoke during the study duration 4. Willing and able to complete protocol required study follow-up assessments and procedures 5. Fit for thoracoscopy under general anaesthesia (surgical and anaesthetic assessment) 6. Recent (\< 18 months) endobronchial lung volume reduction (EBLVR) and lack of response defined by: 1. Persistent symptomatic dyspnoea (mMRC \>2) which in the patient's view is no better than baseline 2. Absence of target lobar collapse with any residual aeration apparent on imaging 3. Persistence of (6a) and (6b) following post procedure StratX CT analysis and revisional bronchoscopy. Exclusion criteria 1. Fissure completeness \<90% on pre EBLVR StratX (i.e less than 10% of fissure to be divided) 2. Chartis positive for collateral ventilation or not performed/not satisfactory at initial EBLVR 3. Quantitative perfusion of target lobe \>25% of total on SPECT assessment. 4. Previous lung surgery or pleurodesis on the target side for LVR. 5. Clinically significant bronchiectasis -greater than 4 tablespoons mucus per day. 6. More than 3 COPD exacerbation episodes in the last year. 7. Evidence of hypercapnia (pCO2 \>7KPa) - ABG to be performed on admission for index procedure 8. Clear evidence of pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or right ventricular dysfunction as determined by a recent echocardiogram (\<12mo) 9. Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (\<12mo) 10. Myocardial infarction within 6 months of screening. 11. Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. 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 ↗

  2. A doctor treating you

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