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An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema

Study acronym: CONVERT_II
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 36 to 38
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Site details revised at 36 of 36 sitesv24
  3. Site details revised at 1 of 36 sitesv23
  4. Study sites: 34 to 36v22
  5. Study sites: 32 to 34v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 26 to 32v20
  2. Study sites: 25 to 26v19
  3. Study description revised
    • Eligibility criteria expanded, about 4 words
    v18
  4. Study sites: 24 to 25v17
  5. Study sites: 23 to 24v16
  6. Study sites: 19 to 23
    • Eligibility criteria expanded, about 9 words
    v15
  7. Study sites: 18 to 19v14
  8. Study sites: 17 to 18v13
  9. Study sites: 16 to 17v12
  10. Study sites: 7 to 16v11
  11. Study sites: 5 to 7v10
  12. Secondary endpoints revised (4)v9
  13. Primary completion date: Jan 31, 2026 to Jun 30, 2027
    • Start date: Nov 6, 2023 to Feb 22, 2024
    v8
  14. Study sites: 4 to 5v7
  15. Study sites: 3 to 4v6
  16. Re-verified, no change to tracked fieldsv5
  17. Study sites: 1 to 3v4
  18. Lead sponsor: [Redacted] to Pulmonx Corporationv3 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Jan 31, 2026
    • Study completion date: Mar 31, 2028
    • Start date: Nov 6, 2023
    • Study title expanded, about 3 words
  19. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pulmonx Corporation
4 trials monitored
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COPD
1,119 trials monitored
See 34 trials at risk
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.
Trial Details
NCT Number NCT06035120
Lead Sponsor Pulmonx Corporation
Conditions
(from sponsor)		 Emphysema, Pulmonary, Emphysema or COPD
Related terms Emphysema, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov