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Surgical fix offers new hope for failed emphysema treatment

NCT ID NCT05257681

Disease control Sponsor: Beth Israel Deaconess Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This pilot study tests a surgical procedure for people with severe emphysema or COPD who did not get enough benefit from a standard treatment using bronchoscopic lung volume reduction (valves). The surgery uses small chest incisions to complete the fissures between lung lobes and remove scar tissue, aiming to reduce air trapping and improve breathing. Up to 20 participants aged 40 to 75 will be enrolled to see if the procedure is feasible and safe.

What this could mean

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

Active substance
surgical procedure (video-assisted thoracoscopic surgery or robotic stapling to complete lung fissures and remove adhesions)
What this could lead to
If it works, this could offer a second chance for emphysema patients who didn't benefit from a less invasive valve procedure, potentially improving breathing and quality of life.
What could go wrong
This is a very small, early pilot study with only 20 people. The surgery is invasive and carries risks like infection, bleeding, or complications that could outweigh benefits. Success is not guaranteed.

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 20 people

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

Started

May 2022

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

40 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: * Age 40 to 75 years. * Stable with less than 10mg prednisone (or equivalent) daily. * Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration. * Current pneumococcus vaccination. * Current influenza vaccination. * Target lung volume reduction \<350ml after bronchoscopic lung volume reduction (BLVR). * Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction (BLVR). * Endobronchial valves (EBV) are still in place. * Willing and able to complete protocol required study follow-up assessments and procedures. Exclusion Criteria: * Clinically significant (greater than 4 tablespoons per day) mucus production. * Myocardial infarction within 6 months of screening. * Decompensated heart failure. * Three or more pneumonia episodes in last year. * Three or more COPD exacerbation episodes in the last year. * Prior lung transplant, LVRS, bullectomy, or lobectomy. * Clinically significant bronchiectasis. * Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days. * Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit). * Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit). * Resting bradycardia (\<50 bpm), Complex ventricular arrhythmia, sustained SVT. * PaCO2 greater than 50mmHg on room air at screening. * PaO2 less than 45mmHg on room air at screening.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease pulmonary emphysema

As listed by the trial registrant

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

Emphysema or COPD

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

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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