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Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

NCT03107494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-09-01

No results posted yet for this study

Summary

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

Conditions

  • Chronic Bronchitis

Interventions

DEVICE

Gala Airway Treatment System

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. In this study, 2 treatment sessions will be delivered 1 month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session. A third bronchoscopy will be performed 3 months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous. Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.

Sponsors & Collaborators

  • Gala Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • William Krimsky, MD · Gala Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2019-02-28
Completion
2019-11-30
FDA Device
Yes

Countries

  • Austria
  • Chile

Study Locations

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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 NCT03107494 on ClinicalTrials.gov