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Gala Early Feasibility Study for the Treatment of Chronic Bronchitis in the United States

2018-08-19 20:17:13 | BioPortfolio

Summary

Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis in the United States.

Description

The Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.

Subjects will be required to submit tests during the study including two CT scans (lung), respiratory function tests, exercise testing.

Study Design

Conditions

Chronic Bronchitis

Intervention

Gala Airway Treatment System

Status

Not yet recruiting

Source

Gala Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-08-19T20:17:13-0400

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