RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: The Spiration IBV Valve System

Status

Open

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

Conditions

Other

Phases

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Modi, Aakash

Practice

Lung

Scope

National

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.

Nct ID Number

Secondary Trial ID Number

H060002/Spiration IBV Valve

Keywords

Humanitarian Device

More Information

clinicaltrials.gov

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