RheOx Registry Study in Europe

COPD Clinical Trial

Official title:

RheOx European Post-Market Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182841
• Other study ID #: CS005
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: December 15, 2025

Study information

• Verified date: March 2022
• Source: Gala Therapeutics, Inc.
• Contact: Jeff Keeney
• Phone: 650-268-4252
• Email: jeff[@]galatherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• COPD

Intervention

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.

Locations

Country	Name	City	State
Austria	Otto Wagner Spital	Wien
Germany	Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Gala Therapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Quality of Life: CAT	COPD Assessment Test (CAT) questionnaire	Through end of study (24 months post bilateral treatment)
Primary	Quality of Life: SGRQ	St. George Respiratory Questionnaire	Through end of study (24 months post-bilateral treatment)
Secondary	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)
Secondary	Pulmonary Function: FVC	Forced Vital Capacity	Through end of study (24 months post-bilateral treatment)
Secondary	COPD Exacerbations	COPD Exacerbations	Through end of study (24 months post-bilateral treatment)