RheOx Registry Study in Europe

Not Applicable

Recruiting

• Conditions: Chronic Bronchitis; COPD
• Interventions: Device: RheOx

• Registration Number: NCT04182841
• Lead Sponsor: Gala Therapeutics, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-02
• Study Start: 2020-01-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22
• Primary Completion: 2024-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RheOx Treatment	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.

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of SAEs	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	Through end of study (24 months post bilateral treatment)	COPD Assessment Test (CAT) questionnaire
Quality of Life: SGRQ	Through end of study (24 months post-bilateral treatment)	St. George Respiratory Questionnaire

Secondary Outcome Measures

Name	Time	Method
Pulmonary Function: FEV1	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	Through end of study (24 months post-bilateral treatment)	Forced Vital Capacity
COPD Exacerbations	Through end of study (24 months post-bilateral treatment)	COPD Exacerbations

Trial Locations

Locations (2)

Otto Wagner Spital; 🇦🇹 Wien, Austria

Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany