Clinical trial NCT04182841: RheOx Registry Study in Europe
Official title: RheOx European Post-Market Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Bronchitis
COPD
Lead sponsor: Gala Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: RheOx Treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety: Incidence of SAEs
timeFrame: Through end of study (24 months post bilateral treatment)
measure: Quality of Life: CAT
timeFrame: Through end of study (24 months post bilateral treatment)
measure: Quality of Life: SGRQ
timeFrame: Through end of study (24 months post-bilateral treatment)
Secondary outcomes:
measure: Pulmonary Function: FEV1
timeFrame: Through end of study (24 months post-bilateral treatment)
measure: Pulmonary Function: FVC
timeFrame: Through end of study (24 months post-bilateral treatment)
measure: COPD Exacerbations
timeFrame: Through end of study (24 months post-bilateral treatment)
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Otto Wagner Spital
city: Heidelberg
country: Germany
facility: Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Gala Therapeutics, Inc.
name: William Krimsky, MD
role: STUDY_DIRECTOR
References: