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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.

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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

FieldValue
Enrollment Target 32 participants
Start Date 2010-04
Est. Completion 2017-07
Phase NA

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.