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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 is a NA study that has completed, run by Olympus Corporation of the Americas. The registered enrollment target is 32 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166516
The ClinicalTrials.gov registry entry for NCT01166516 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olympus Corporation of the Americas, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Treatment with HUD IBV Valve System is the first listed.
NCT01166516 reports 0 study locations.
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.
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