A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Chinese Adult Patients With COPD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Bronchitis
- Sponsor
- Energenx Medical LTD.
- Enrollment
- 40
- Locations
- 7
- Primary Endpoint
- COPD Assessment Test (CAT) Score in Total
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject's age is ≥35 years and ≤80 years
- •Subject has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
- •Subject has a CAT score ≥
- •Subject's responses to the first two questions of the CAT questionnaire sum to ≥ 7 points or the sum is 6 points and the subject's total CAT score is \> 20 points.
- •Subject has a SGRQ score ≥
- •Subject has post -bronchodilator FEV1/FVC \< 0.
- •Subject has post-bronchodilator FEV1 percent predicted of ≥ 30%.
- •Subject is receiving guideline directed pharmacotherapy which includes one or more long-acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to enrollment.
- •Subject has a cigarette smoking history of at least ten pack years (packs per day x years of smoking), and has had quit smoking for at least 6 months before enrollment;
- •In the opinion of the investigator, subject is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule.
Exclusion Criteria
- •Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
- •Subject has a pulmonary nodule or cavity . In the judgement of the investigator, the subject may require intervention during the course of the study.
- •Subject has clinically significant bronchiectasis influencing the subject's clinical symptoms of cough and phlegm.
- •Subject has severe other lung diseases (including interstitial pneumonia, lung fibrosis, pulmonary fibrosis with emphysema, atelectasis, unresolved lung Cancer, giant pulmonary bullae);
- •Subject has asthma based on Global Initiative for Asthma (GINA) criteria.
- •Subject has had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.
- •Subject had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable
- •Subject has a history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, grade II, II or III AV transmission history of conduction blockor, sinus bradycardia with heart rate less than 45 beats per minute.
- •Subject is on anticoagulation for cardiovascular indications and, at the discretion of the investigator, is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for the bronchoscopy procedure per institution's standard of care.
- •\* If the anticoagulants withheld is clinically acceptable, five to seven days withheld before enrollment is advised.
Outcomes
Primary Outcomes
COPD Assessment Test (CAT) Score in Total
Time Frame: 6 Month after second RheOx procedure (treatment 2 on left lung )
The mean change from baseline to Month 6. (The minimal is zero and maximal 40 points. The higher score means the impact is greater)
Secondary Outcomes
- CAT Score in Total(12 months)
- St. George's Respiratory Questionnaire (SGRQ)(12 months)
- CAT response rate(12 months)
- SGRQ response rate(12 months)
- Distal airway volume(Month 6)
- Total Airway Counts(Month 6)