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Chronic BronchitisNCT05641207

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System

A study testing RheOx™ with the RheOx™ Catheter treated in the trial in people with Chronic Bronchitis and Chronic Obstructive Pulmonary Disease, run by Energenx Medical LTD. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
RheOx™ with the RheOx™ Catheter treated in the trial
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesChina
Study dates
18 May 2023to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Xinqiao Hospital, Army Medical University

    Chongqing, Chongqing Municipality

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang

  • The Tenth People's Hospital of Shanghai

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
RheOx™ with the RheOx™ Catheter treated in the trial
Medical subject headings
Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RheOx™ with the RheOx™ Catheter treated in the trialDevice

    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
Study groups in NCT05641207
Study groupRoleWhat they receive
Experimental device RheOx™ with the RheOx™ Catheter was only used in the trialExperimentalAll of participants who signed the ICF and meet all of inclution and exclution criterias will be enrolled to experimental arm.
Receives: Device: RheOx™ with the RheOx™ Catheter treated in the trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 Month after second RheOx procedure (treatment 2 on left lung )

Secondary outcomes (6)

  1. 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)

    Measured: 12 months

  2. 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)

    Measured: 12 months

  3. CAT response rate

    At 3, 6 and 12 months after RheOx procedures

    Measured: 12 months

  4. SGRQ response rate

    At 3, 6 and 12 months after RheOx procedures

    Measured: 12 months

  5. 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

    Measured: Month 6

  6. Total Airway Counts

    The mean change from baseline to Month 6 in Total Airway Counts(TAC) as determined by an independent core lab

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start18 May 2023
  3. Primary completion30 Apr 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
An intervention of a device product
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05641207
Sponsor's protocol ID
CCS-001
Status last verified
Aug 2026
First submitted
17 Nov 2022
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing RheOx™ with the RheOx™ Catheter treated in the trial in people with Chronic Bronchitis and Chronic Obstructive Pulmonary Disease, run by Energenx Medical LTD. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COPD Assessment Test (CAT) Score in Total (time frame: 6 Month after second RheOx procedure (treatment 2 on left lung )). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05641207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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