- An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT06035120.
- This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using….
- Sponsor: Pulmonx Corporation.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
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- Subject is willing and able to provide informed consent and to participate in the study.
- Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.
- Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.
- Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.