Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion

NCT04465461 | Completed FDA Device

• 1 other identifier: 630-0026-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, multi-centre, pilot study aimed to evaluate the effect of Video Assisted Thoracic Surgery (VATS) fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe Chronic Obstructive Pulmonary Disease (COPD) who exhibit collateral ventilation.

Conditions

Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

• Residual Volume (RV)

  Absolute Change in Residual Volume (RV) from baseline to 6-months post Zephyr Valve procedure.

  6 months

Secondary Outcomes (7)

• Forced Vital Capacity (FVC)

  6 months

• Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC)

  6 months

• Total Lung Capacity (TLC)

  6 months

• Six-Minute Walk Test (6MWT)

  6 months

• St. George's Respiratory Questionnaire (SGRQ) Total Score

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients exhibiting baseline collateral ventilation by Chartis® balloon catheter assessment who undergo video-assisted thoracoscopic surgery (VATS) fissure completion surgery, confirmation of fissure completion by computerized tomography (CT) scan and confirmation of conversion to collateral ventilation negative by Chartis® balloon catheter assessment post VATS surgery and subsequent Zephyr Valve insertion.

Procedure: Video-assisted thoracoscopic surgery (VATS) fissure completion; Device: Zephyr Valve insertion

Interventions

Video-assisted thoracoscopic surgery (VATS) fissure completion PROCEDURE

Following Bronchoscopy and Chartis® balloon catheter assessment under general anaesthesia and confirmation of collateral ventilation, a unilateral VATS lobar fissure completion will be undertaken with buttressed staples and Coseal spray intended to eliminate collateral ventilation.

Treatment

Zephyr Valve insertion DEVICE

Following fissure completion surgery, subjects confirmed to be collateral ventilation negative will undergo bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.

Also known as: Bronchoscopic Lung Volume Reduction (BLVR)

Treatment

Eligibility Criteria

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

You may qualify if:

• Subject is willing and able to provide informed consent and to participate in the study.
• Subject is ≥ 40 years of age.
• Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (Global Initiative for Obstructive Lung Disease (GOLD) classification).
• Subject has a post bronchodilator 15% ≤ FEV1 ≤ 50%.
• Subject has Total Lung Capacity (TLC) ≥ 100% predicted.
• Subject has Residual Volume (RV) ≥ 150% predicted.
• Subject has a normal dobutamine stress echocardiogram.
• Subject has sufficient exercise tolerance i.e. 150m ≤ 6MWT ≤ 450m.
• Subject has an incomplete lobar fissure i.e. \< 90%, as confirmed by CT evaluation of lung fissures.
• Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation)
• Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhaemoglobin or cotinine levels.
• Subject is up to date with preventive vaccinations including seasonal influenza vaccine and pneumococcal vaccine consistent with the Victorian Department of Health and Human Services Immunization Schedule Guidelines (updated March 2018).

You may not qualify if:

• Subject has a history of previous thoracotomy, lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any form.
• Subject has an acute COPD exacerbation.
• Subject has evidence of active respiratory infection.
• Subject has a post bronchodilator FEV1 \< 15%.
• Subject has a Diffusing capacity for carbon monoxide (DLCO) \< 20%.
• Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the 12 months prior to study enrollment (Informed Consent Form signature page).
• Subject has severe gas exchange abnormalities as defined by any one of the following:
• Partial pressure of oxygen (PaO2) \< 60 mmHg
• Partial pressure of carbon dioxide (PaCO2) \> 45 mmHg
• Oxygen saturation (SpO2) \< 90% on ≥ 4 L/min supplemental O2 at rest
• Subject use of systemic steroids \> 20mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure.
• Subject unable to temporarily interrupt use of heparins or oral anticoagulants or antiplatelet agents, excluding aspirin.
• Subject's pre-operative CT scan indicates the presence of any of the following radiological abnormalities:
• Pulmonary nodule ≥ 0.8 cm in diameter (does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/positron emission tomography (PET)).
• Radiological picture consistent with active pulmonary infection, e.g. unexplained parenchymal infiltrate.

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (2)

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

St. Vincent's Private Hospital Fitzroy

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Pulmonary Emphysema

Interventions

Thoracic Surgery, Video-Assisted; Pneumonectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Pulmonary Surgical Procedures

Study Officials

• Naveed Alam, MD

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: June 4, 2020
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)