A Clinical Evaluation of the RheOx Bronchial Rheoplasty System
NCT05641207 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-06-26
Summary
This is a prospective, multicenter, single arm and open-label clinical trial to evaluate the performance, effectiveness and safety of RheOx™ system in the treatment of the symptoms of chronic bronchitis in adult moderate to severe COPD patients.
Conditions
- Chronic Bronchitis
- Chronic Obstructive Pulmonary Disease
Interventions
- DEVICE
-
RheOx™ with the RheOx™ Catheter treated in the trial
Eligible patients be assigned two sessions of RheOx bronchial rheoplasty procedures * Treatment 1 is for the treatment of right lung * Treatment 2 is scheduled one month apart for left lung
Sponsors & Collaborators
-
Energenx Medical LTD.
lead INDUSTRY
Principal Investigators
-
Guangfa WANG, MD · Peking University First Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 35 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-18
- Primary Completion
- 2025-08-31
- Completion
- 2025-11-30
Countries
- China
Study Locations
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