A Prospective Study with the IBV Valve System for the Treatment of Prolonged Air Leak

Study ID
STU 122012-056

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul

Contact
Megha Sharma
214-645-6489
megha.sharma@utsouthwestern.edu

Principal Investigator
Muhanned Abu-Hijleh

Summary

The Spiration iBV Valve System is intended to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).

iBV Valve System has been used to treat patients with post-operative prolonged air leaks
under the iDe compassionate use (Cu) regulations. The goal of using the iBV Valve
System for air leak is to accelerate the resolution of this post-operative complication in
order to:
* Reduce hospital days, and
* avoid additional complications related to:
o air leaks, and
o The prolonged use of chest tubes in a hospital setting
iBV Valve System use is limited to 6 weeks per prolonged air leak.

Potential subjects will recieve the iBV Valve System as Standard of Care. the iBV devis is not being researched for this study. Subjects will be followed to monitor changes and resolution of the air leak and adverse events.

Participant Eligibility

Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung
volume reduction surgery (LVRS), or on day 5 if the air leak 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. The subjects have agreed and the doctor's recommendations is for IBV valve treatement.