NCT04465461

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

A Pilot Study of Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion for Severe Chronic Obstructive Pulmonary Disease (COPD) in Patients With COllateral VEntilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pulmonx Corporation · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be a prospective, multi-centre, pilot study aimed to evaluate the effect of VATS fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe COPD who exhibit collateral ventilation. Study patients who provide informed consent and meet the initial inclusion/exclusion criteria following baseline screening assessments and multidisciplinary review to determine eligibility will undergo two procedures, not less than 28 days apart. The first procedure will involve an initial bronchoscopy and Chartis® assessment of collateral ventilation under general anaesthesia followed by a VATS fissure completion between targeted lobes in subjects that have collateral ventilation. The second procedure undertaken following fissure completion surgery will involve bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia. Subjects will be followed up over a 6-month period following VATS fissure completion and Zephyr® Endobronchial Valve (Zephyr Valve) insertion.

Conditions

• Pulmonary Emphysema

Interventions

Type	Name	Description
PROCEDURE	Video-assisted thoracoscopic surgery (VATS) fissure completion	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.
DEVICE	Zephyr Valve insertion	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.

Timeline

• Start date: 2020-06-04
• Primary completion: 2024-03-05
• Completion: 2024-03-05
• First posted: 2020-07-10
• Last updated: 2025-04-29

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated device study