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A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

Study acronym: IAB-1
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date changed from estimate of Apr 1, 2024 to Mar 27, 2024v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 20
    • Primary completion date: Jan 2024 to Apr 1, 2024
    • Site details revised at 3 of 3 sites
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Primary completion date: Jun 2023 to Jan 2024
    • Study completion date: Nov 2025 to Jan 2027
    • Site details revised at 1 of 3 sites
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2022 to May 3, 2022
    • Secondary endpoints: details revised at 2 of 14 entries
    • Site details revised at 3 of 3 sites
    v3
  2. Start date: Dec 2021 to May 2022
    • Study completion date: Mar 2025 to Nov 2025
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Pulmair Medical, Inc.
3 trials monitored
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COPD
1,119 trials monitored
See 34 trials at risk
The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes. The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose. The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.
Trial Details
NCT Number NCT05087641
Lead Sponsor Pulmair Medical, Inc.
Conditions
(from sponsor)		 Emphysema, Pulmonary Disease, Chronic Obstructive
Related terms Emphysema, Pulmonary Disease, Chronic Obstructive
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov