RheOx Registry Study in Europe

Overview

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

Full Title of Study: “RheOx European Post-Market Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 15, 2024

Detailed Description

RheOx 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 anaesthesia. 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 to several tests and questionnaires during the study including respiratory function tests.

Interventions

  • Device: RheOx
    • RheOX is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Arms, Groups and Cohorts

  • Other: RheOx Treatment
    • RheOx is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Clinical Trial Outcome Measures

Primary Measures

  • Safety: Incidence of SAEs
    • Time Frame: Through end of study (24 months post bilateral treatment)
    • Incidence of serious adverse events associated with RheOx treatment through 24 months
  • Quality of Life: CAT
    • Time Frame: Through end of study (24 months post bilateral treatment)
    • COPD Assessment Test (CAT) questionnaire
  • Quality of Life: SGRQ
    • Time Frame: Through end of study (24 months post-bilateral treatment)
    • St. George Respiratory Questionnaire

Secondary Measures

  • Pulmonary Function: FEV1
    • Time Frame: Through end of study (24 months post-bilateral treatment)
    • Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.
  • Pulmonary Function: FVC
    • Time Frame: Through end of study (24 months post-bilateral treatment)
    • Forced Vital Capacity
  • COPD Exacerbations
    • Time Frame: Through end of study (24 months post-bilateral treatment)
    • COPD Exacerbations

Participating in This Clinical Trial

Inclusion Criteria

  • Patient has moderate to severe Chronic Bronchitis

Exclusion Criteria

  • Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device.
  • Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block.
  • Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gala Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William Krimsky, MD, Study Director, Gala Therapeutics, Inc.
  • Overall Contact(s)
    • Jeff Keeney, 650-268-4252, jeff@galatherapeutics.com

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