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One lung or two? surgery trial aims to find the best approach for severe COPD

NCT ID NCT07731958

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether operating on just one lung works as well as operating on both lungs for people with severe COPD and emphysema. The goal is to see if a less invasive approach can improve lung function with fewer risks. About 146 participants will be randomly assigned to one of the two procedures and followed for key outcomes like breathing capacity and survival.

What this could mean

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

Active substance
lung volume reduction surgery (LVRS) performed on one or both lungs
What this could lead to
If one-lung surgery works as well as two-lung surgery, it could mean fewer complications and faster recovery for patients with severe COPD.
What could go wrong
This is a single-center trial with 146 participants, so results may not apply to all patients. Surgery carries risks like infection, air leaks, and serious complications.

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 146 people

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

Started

Mar 2025

Expected to finish

Jul 2032

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 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: * Suitable target areas in both lungs * Age ≥ 18 years. * Speaks and understands Danish or English * Informed consent obtained * Usual inclusion criteria in LVRS: Moderate to severe COPD with MRC score \> 2 \< 75 years old 17 \< BMI \> 30 FEV1 \> 20% and \< 45% of predicted RV \> 200% of predicted as a sign of relevant hyperinflation DLCO \> 20% of predicted The patient should be in ideal medical treatment and have completed rehabilitation A high-resolution CT \< 3 months old should follow the referral to MDT Absence of nodules suspicious of malignancy on CT scan Absence of significant comorbidity including severe cardiovascular disease LVEF normal Absence of pulmonary hypertension, TI-gradient \< 40 mmHg Absence of chronic or frequent lung infections Smoking abstinence six months prior to surgery Assessed as sufficiently physically fit to undergo surgery and rehabilitation Exclusion Criteria: * Dependent on wheelchair * Living in nursery home * Dependent on walker device * Psychiatric disorder (anxiety, depression, schizophrenia) * Simultaneous lung cancer surgery * Massive adhesions during surgery assessed by the surgeon indicating problems postoperatively * Increased risk of post-operative bleeding assessed perioperatively by the surgeon. * Perioperative decision on not doing operation on the other side (medical, surgical or anaesthesiologic problems that favours a fast termination of the surgery, decided by the team in OR). * Previous cardiothoracic surgery * Increased bleeding risk (e.g., preoperative INR \>2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease Dyspnea pulmonary emphysema

As listed by the trial registrant

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

Emphysema, pulmonary

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

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2300, Denmark

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