Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema

NCT04801108 | Recruiting DMC FDA Device

• 1 other identifier: 2021P000049
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling. The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.

Conditions

Emphysema or COPD

Keywords

COPD; Endobronchial valves; Emphysema; Video-assisted thoracic surgery; Robotic thoracic surgery

Outcome Measures

Primary Outcomes (3)

• Prove that inter-lobar fissures can be completed to at least 95% via robotic thoracic surgery or VATS in severe emphysema patients

  We will determine that we met this feasibility objective if the target inter-lobar fissure can be completed in at least 90% of the patients undergoing surgery.

  2 years

• Prove that patients consented for the procedure will ultimately undergo the intervention

  We will determine that the study is feasible if at least 90% of consented patients in the intervention arm undergo the procedure.

  2 years

• Incidence of severe adverse events

  We will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the combined procedure. In case the treating physicians consider that the complications seen in patients outweigh the benefits obtained, the surgical technique will be revised and possible changes will be discussed.

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• Percentage of patients to achieve target lung volume reduction

  2 years

• Percentage of patients with quality of life improvement

  2 years

• Percentage of patients with significant changes in pulmonary function testing

  2 years

Study Arms (3)

Medical management group

NO INTERVENTION

COPD patients with severe emphysema and incomplete lobar fissures will be placed on maximal medical therapy for 3 months. At the end of this 3 month period, patients will fill in an additional set of quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. New pulmonary function testing will be performed and crossover to the intervention group will be offered.

Intervention group

EXPERIMENTAL

COPD patients with severe emphysema and incomplete lobar fissures will undergo video-assisted thoracic surgery fissure completion and valves placement. 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.

Procedure: Robotic or VATS lobar fissure completion; Device: Endobronchial valves placement

Crossover group

EXPERIMENTAL

Subjects allocated to the medical management group will be offered to crossover after the 3 months follow-up period. The same procedure as in the intervention group will be performed. Follow-up after surgery will be the same as in the intervention group.

Procedure: Robotic or VATS lobar fissure completion; Device: Endobronchial valves placement

Interventions

Robotic or VATS lobar fissure completion PROCEDURE

The lobar fissure adjacent to the target lobe will be completed using a surgical stapler through robotic or video-assisted thoracic surgery.

Crossover group; Intervention group

Endobronchial valves placement DEVICE

Endobronchial valves will be placed in the target lobe after the fissure completion.

Crossover group; Intervention group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
• Current pneumococcus vaccination.
• Current influenza vaccination.
• Willing and able to complete protocol required study follow-up assessments and procedures.

You may not qualify if:

• \> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
• Clinically significant (greater than 4 tablespoons per day) mucus production.
• Myocardial infarction within 6 months of screening.
• Uncontrolled congestive 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 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.
• Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening.
• TLC less than 100% predicted (determined by body plethysmography at screening).
• RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening).

Sponsors & Collaborators

• Pulmonx Corporation: collaborator
• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

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MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Interventions

Robotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Automation; Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Interventional Pulmonology

Model Details: This pilot randomized controlled trial is expected to enroll a total of 20 subjects with a follow-up period of 3 months. All interventions and follow-up will be performed at the BIDMC. Patients will be randomized to an intervention or medical management group using an opaque envelope technique in a 2-4 block pattern to assure a random and evenly distributed patient population. After the patient allocated to the medical management, the arm is followed for 3 months, they will be offered the robotic or VATS fissure completion procedure. It will be completely up to the candidates to undergo the intervention. If they decide that they want to proceed with surgery, the previously described methods will be used including the same surgical technique, same postoperative management, and same follow-up timelines and datapoints.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 16, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)