RheOx Registry Study in Europe

RheOx European Post-Market Clinical Study

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

Study Overview

• Status: Recruiting
• Conditions: COPD; Chronic Bronchitis
• Intervention / Treatment: Device: RheOx

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeff Keeney; Phone Number: 650-268-4252; Email: jeff@galatherapeutics.com

Study Locations

• Austria
  • Wien, Austria, A-1140
    • Recruiting
    • Otto Wagner Spital
    • Contact: Kelly Gross; Phone Number: 0043 664 4385355; Email: blvr.koordinator@gmail.com
• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69047
      • Recruiting
      • Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg
      • Principal Investigator: Felix Herth, MD
      • Contact: Brigitte Rump; Phone Number: 49 (6221) 396-1211; Email: brigitte.rump@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gala Therapeutics, Inc.
• Investigators: Study Director: William Krimsky, MD, Gala Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Anticipated): December 15, 2024
• Study Completion (Anticipated): December 15, 2025

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: CS005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes