NCT04559464: CONVERT

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

Completed NA Last updated 4 November 2024

What this trial tests

NA trial testing AeriSeal in Emphysema in 102 participants. Completed in 21 October 2024.

Timeline

15 December 2020

Primary endpoint
24 October 2023

21 October 2024

Quick facts

Lead sponsor	Pulmonx Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	15 December 2020
Primary completion	24 October 2023
Estimated completion	21 October 2024
Sites	14 locations across France, Italy, Netherlands, United Kingdom, Germany, Switzerland, Australia

Drugs / interventions tested

• AeriSeal
• Zephyr Valves

Conditions studied

• Emphysema — all drugs for Emphysema →
• COPD — all drugs for COPD →
• Severe Emphysema — all drugs for Severe Emphysema →

Sponsor

Pulmonx Corporation — full company profile →

Who can join

Adults 40 to 75, any sex, with Emphysema or COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:

• Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.

Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.

• Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).

Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surgical and bronchoscopic pulmonary function-improving procedures in lung emphysema.
   Everaerts S, Vandervelde CM, Shah P, Slebos DJ, et al · · 2023 · cited 10× · PMID 38123230 · DOI 10.1183/16000617.0004-2023
2. Crosslink bio-adhesives for bronchoscopic lung volume reduction: current status and future direction.
   Joglekar MM, Slebos DJ, Leijten J, Burgess JK, et al · · 2021 · cited 9× · PMID 34853096 · DOI 10.1183/16000617.0142-2021
3. Determinants of Lung Fissure Completeness.
   van der Molen MC, Hartman JE, Vermeulen CJ, van den Berge M, et al · · 2021 · cited 7× · PMID 34126038 · DOI 10.1164/rccm.202102-0260oc
4. Which Endoscopic Procedure to Use and in What Patient? Valves, Coils, Foam, and Heat in COPD and Asthma.
   Li A, Lee P. · · 2023 · cited 3× · PMID 36534323 · DOI 10.1007/s41030-022-00208-6
5. ERS International Congress 2023: highlights from the Clinical Techniques, Imaging and Endoscopy Assembly.
   Moretti A, Pietersen PI, Hassan M, Shafiek H, et al · · 2024 · cited 2× · PMID 38410712 · DOI 10.1183/23120541.00836-2023
6. Lung Fissural Integrity: It's Written in the Genes.
   Garner JL, Desai SR. · · 2021 · cited 2× · PMID 34352193 · DOI 10.1164/rccm.202106-1526ed