Clinical Trial ID:
The Spiration IBV Valve System
Description
The Spiration IBV Valve System is 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 lung volume reduction surgery (LVRS). An air leak present on postoperative
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. IBV Valve System use is limited to six weeks per prolonged air leak.
Objective
The Spiration IBV Valve System is 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 lung volume reduction surgery (LVRS).
Treatment
TABLE 1: IBV Valve Biocompatibility Testing and Results
TABLE 2: Deployment Catheter Biocompatibility Testing and Results
Main Investiagtor
Modi, Aakash
Participating Institutions
BMDACC Clinical Trials Office
Eligibility
Directions for use: See the Physician's Labeling.
Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings,
Precautions and Adverse Events in the labeling.
Postapproval Requirements and Restrictions: See Approval Order.
Secondary Trial ID Number
H060002/Spiration IBV Valve
Keywords
Humanitarian Device