Trials / Active Not Recruiting
Active Not RecruitingNCT05641207
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Chinese Adult Patients With COPD
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Energenx Medical LTD. · Industry
- Sex
- All
- Age
- 35 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Eligible patients will be assigned to two sessions of treatments with RheOx™ system. Treatment 1, named initial procedure is scheduled at right lung. And then treatment 2 is planned to treat left lung one month apart from initial procedure. Following-up post either RheOx procedure is scheduled at 2nd day discharged from hospital and day 14 (phone call) and 1 month. Patients will undergo follow-up evaluations at Month 3, 6 and 12 post-treatment 2. And a phone call is also scheduled every two months post treatment 2 except the above. The assessments will include quality of life questionnaires, pulmonary function testing, lung CT scan and monitoring any adverse events and also any changes in inhaled medication, unschedule clinic visit or ER visit and even hosptialization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-05-18
- Primary completion
- 2025-08-01
- Completion
- 2025-11-01
- First posted
- 2022-12-07
- Last updated
- 2025-06-26
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05641207. Inclusion in this directory is not an endorsement.