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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis
• Intervention / Treatment: Device: RheOx™ with the RheOx™ Catheter treated in the trial

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University First Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Xinqiao Hospital, Army Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • First Affiliated Hospital of Guangzhou Medical University
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
  • Shanghai
    • Shanghai, Shanghai, China
      • The Tenth People's Hospital of Shanghai
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject's age is ≥35 years and ≤80 years
2. 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.
3. Subject has a CAT score ≥ 10.
4. 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.
5. Subject has a SGRQ score ≥ 25.
6. Subject has post -bronchodilator FEV1/FVC < 0.7.
7. Subject has post-bronchodilator FEV1 percent predicted of ≥ 30%.
8. 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.
9. 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;
10. 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.

Subject has provided informed consent.

Exclusion Criteria:

1. Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
2. Subject has a pulmonary nodule or cavity . In the judgement of the investigator, the subject may require intervention during the course of the study.
3. Subject has clinically significant bronchiectasis influencing the subject's clinical symptoms of cough and phlegm.
4. Subject has severe other lung diseases (including interstitial pneumonia, lung fibrosis, pulmonary fibrosis with emphysema, atelectasis, unresolved lung Cancer, giant pulmonary bullae);
5. Subject has asthma based on Global Initiative for Asthma (GINA) criteria.
6. 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.
7. 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
8. 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.

9. 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.

10. Subject has other serious diseases (e.g. congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver failure, cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
11. Subject has uncontrolled gastroesophageal reflux disease（GERD）that indicated by the common symptoms and signs like stomach burning, acid reflux, regurgitation of partial digested food or acid into throat.
12. Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
13. Subject has known airway colonization with resistant organisms, such as pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus mucor or significant fungus.
14. Subject has known severe pulmonary hypertension.
15. Subject has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines, Propofol).
16. Subject has known allergy to nickel.

17. Subject is receiving any traditional Chines herbs for cough or phlegm. * mucolytics may be recommended by institute clinical practice, carbocysteine, oral or inhaled N-acetylcysteine, Eucalyptol and ambroxol hydrochloride are suggested.

    * The treatrment of this study is to ablate bronchial mucosa by airway intervention, then mucosa epithelium is repaired. The effect of inhalation on the repair of airway mucosal epithelium is unknown. Therefore, it is not recommended to oral or inhaled N-acetylcysteine during treatment and follow-up.

18. Subject has a steroid-dependent condition requiring >10 mg of oral corticosteroid (e.g. prednisone or equivalence.) per day.
19. Subject is unable to walk over 225 meters in 6 minutes.
20. Subject has emphysema of greater than or equal to 35% (low attenuation area≤ -950HU) as determined by HRCT quantitative analysis.
21. Subject is pregnant, nursing, or planning to get pregnant during study duration.
22. Subject has HIV infection or active syphilis infection;
23. Subject is currently participating in another clinical study involving an investigational product.
24. Subject is not suitable for bronchoscopy by the judgement of investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental device RheOx™ with the RheOx™ Catheter was only used in the trial; All of participants who signed the ICF and meet all of inclution and exclution criterias will be enrolled to experimental arm.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test (CAT) Score in Total	The mean change from baseline to Month 6. (The minimal is zero and maximal 40 points. The higher score means the impact is greater)	6 Month after second RheOx procedure (treatment 2 on left lung )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAT response rate	At 3, 6 and 12 months after RheOx procedures	12 months
SGRQ response rate	At 3, 6 and 12 months after RheOx procedures	12 months
Distal airway volume	The mean change from baseline to Month 6 in distal airway volume (DAV) at expiration, as determined by an independent core lab	Month 6
CAT Score in Total	The mean change from baseline to 3，12 months (The minimal is zero and maximal 40 points. The higher score means the impact is greater)	12 months
St. George's Respiratory Questionnaire (SGRQ)	The mean change of SGRQ total score from baseline to 3，6 and 12 months(The minimal is zero and maximal 100 points. The higher score means the impact is greater)	12 months
Total Airway Counts	The mean change from baseline to Month 6 in Total Airway Counts(TAC) as determined by an independent core lab	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough and Sputum Questionnaire (CASA-Q) score	The mean change from baseline to 3, 6 and 12 months. (There are four dominants with its score range acordingly. Cough symptem 0-12, Cough Impact 0-32, Phlegm Symptem 0-12 and Phlegm Impact 0-24. The higher score indicates the better conditions)	12 months
Moderate and/or severe acute excerbation of COPD（AECOPD) post RheOx rheoplasty treatment	RheOx treatment to 12 months (30 days recovery period post treatment not included).	12 months
Total lung capacity(TLC), functional residual capacity (FRC) and inspiratory capacity (IC)	Change measured by computed tomograph scan at full breath-in and at end of tidal breath-out. Inspiratory capacity to be calculated by TLC minue FRC and the change from baseline to 6 months	6 months
6 minute walk distance(6MWT)	the mean change from baseline to 3, 6 and 12 month	12 months

Collaborators and Investigators

• Sponsor: Energenx Medical LTD.
• Investigators: Principal Investigator: Guangfa WANG, MD, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 21, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: CCS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No