MedTrace Logo

IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study

NCT01166516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-04-17

No results posted yet for this 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.

Conditions

  • Prolonged Air Leak

Interventions

DEVICE

Treatment with HUD IBV Valve System

Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Douglas E. Wood, MD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-03-31
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166516 on ClinicalTrials.gov