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NCT01166516 · ClinicalTrials.gov registry record · NA
IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
A NA study, sponsored by Olympus Corporation of the Americas.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT01166516: Completed NA study, sponsored by Olympus Corporation of the Americas.
NCT01166516 is a NA study that has completed, run by Olympus Corporation of the Americas. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01166516, a NA study, has completed, sponsored by Olympus Corporation of the Americas.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
Study to collect post-market safety data for HUD IBV Valve System, a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1)continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
Primary Outcome
The primary objective of this study is to characterize the device safety profile. Adverse events (AEs) reported during the study will be analyzed and summarized. This information will be used to enhance the HDE device labeling.
Interventions
- DEVICE Treatment with HUD IBV Valve System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-04 |
| Est. Completion | 2017-07 |
| Phase | NA |
What the finished NCT01166516 record still lists
NCT01166516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment with HUD IBV Valve System is the first listed.
NCT01166516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01166516 about?
NCT01166516 is a clinical study titled "IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study". Study to collect post-market safety data for HUD IBV Valve System, a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative day 7 is considered prolon...
What is the current status of trial NCT01166516?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2010-04. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01166516?
The interventions under investigation include: Treatment with HUD IBV Valve System (DEVICE).
Who is sponsoring clinical trial NCT01166516?
This trial is sponsored by Olympus Corporation of the Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01166516's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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