Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT)

NACompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

October 24, 2023

Study Completion Date

October 21, 2024

Conditions
EmphysemaCOPDSevere Emphysema
Interventions
DEVICE

AeriSeal

The AeriSeal Foam functions by blocking both small airways and collateral channels causing absorption atelectasis in the treated region of the lung. Occlusion with the foam also yields a targeted fibrotic response which durably reduces lung hyperinflation. The reduction in hyperinflation allows the healthier parts of the lung to re-inflate and improve breathing mechanics and gas exchange. In this study, the AeriSeal delivery will be limited to three segments that contain the collateral channel(s) between lung lobes. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments.

DEVICE

Zephyr Valves

The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.

Trial Locations (14)

8006

University Hospital of Zurich, Zurich

10117

Charité - Universitätsmedizin Berlin, Berlin

25123

ASST Spedali Civili, University Hospital, Brescia

31059

CHU Toulouse, Toulouse

45239

Ruhrlandklinik Essen, Essen

69126

ThoraxKlinik, Heidelberg

87042

CHU Limoges, Limoges

Unknown

The Wesley Hospital, Brisbane

Macquarie University Hospital, Sydney

9700 RB

University Medical Center Groningen, Groningen

G81 4DY

Golden Jublilee National Hospital, Clydebank

CF14 4XW

University Hospital of Wales, Cardiff

SW3 6NP

Royal Brompton Hospital, London

NG5 1PB

Nottingham University Hospitals, Nottingham

All Listed Sponsors
lead

Pulmonx Corporation

INDUSTRY

NCT04559464 - Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT) | Biotech Hunter | Biotech Hunter