Recruiting

Lung Volume Reduction

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05257681

Conditions

Emphysema or COPD

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Interlobar fissure completion and pleural adhesiolysis

Study Details

Brief summary:

The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.

Conditions

Emphysema or COPD

Study ID

NCT05257681

Start date

May 24, 2022

Status verified date

Aug, 2026

Completion date

May 24, 2027

Anticipated

Primary completion date

Dec 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fissure completion and adhesiolysis arm

Patients will undergo a VATS or robotic interlobar lung fissure completion with pleural adhesiolysis. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.

Interventions

Interlobar fissure completion and pleural adhesiolysis

A video-assisted thoracic surgery or robotic approach will be used to perform pleural adhesiolysis and the lobar fissure adjacent to the previously targeted lobe during bronchoscopic lung volume reduction will be completed using a surgical stapler.

Primary outcome measure

  • Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction [ Time Frame: 2 years ]
  • Incidence of severe adverse events [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Adnan Majid, MD FCCP

617 6328252amajid@bidmc.harvard.edu

Principal Investigator:

Adnan Majid, MD FCCP

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • COPD
  • Chronic Obstructive Lung Disease
  • Chronic Obstructive Pulmonary Disease
  • Emphysema
  • Video-assisted thoracic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-08-28.