NCT04182841

RheOx Registry Study in Europe

RheOx European Post-Market Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Gala Therapeutics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Bronchitis
• COPD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-09
• Primary completion: 2024-12-15
• Completion: 2025-12-15
• First posted: 2019-12-02
• Last updated: 2022-03-22

Locations

2 sites across 2 countries: Austria, Germany