A Clinical Evaluation of the RheOx Bronchial Rheoplasty System

NCT05641207 | Active Not Recruiting

• 1 other identifier: CCS-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (4)

• Cough and Sputum Questionnaire (CASA-Q) score

  12 months

• Moderate and/or severe acute excerbation of COPD（AECOPD) post RheOx rheoplasty treatment

  12 months

• Total lung capacity(TLC), functional residual capacity (FRC) and inspiratory capacity (IC)

  6 months

Study Arms (1)

Experimental device RheOx™ with the RheOx™ Catheter was only used in the trial

EXPERIMENTAL

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

Interventions

RheOx™ with the RheOx™ Catheter treated in the trial DEVICE

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

Experimental device RheOx™ with the RheOx™ Catheter was only used in the trial

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 10.
• 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 ≥ 25.
• Subject has post -bronchodilator FEV1/FVC \< 0.7.
• 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.
• Subject has provided informed consent.

You may not qualify if:

• 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.
• 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).
• 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.
• Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
• 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.
• Subject has known severe pulmonary hypertension.

Sponsors & Collaborators

• Energenx Medical LTD.: lead

Study Sites (7)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Xinqiao Hospital, Army Medical University

Chongqing, Chongqing Municipality, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Tenth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangfa WANG, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An intervention of a device product

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 7, 2022
• Study Start: May 18, 2023
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (7)