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Chronic BronchitisNCT07068438

Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease

A study testing Pulse electric field ablation system in people with Chronic Bronchitis and COPD (Chronic Obstructive Pulmonary Disease), run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, randomized, parallel group, sham-controlled, multicenter clinical trial. The objective is to evaluate the safety and effectiveness of pulsed electric field ablation system manufactured by Suzhou Hengruihongyuan Medical Technology Co., Ltd. Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
Pulse electric field ablation system
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
13 sitesChina
Study dates
1 Sep 2025to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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.
  • Patient 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.
  • Patient has a CAT score ≥ 10.
  • Patient has an SGRQ score ≥ 25.
  • Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is > 20 points.
  • Patient has FEV1/FVC < 0.70.
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  • Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
  • Patient 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 randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
  • In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule.
  • Informed consent signed by the patient or legal representative.

Who cannot join

  • Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
  • Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
  • Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
  • Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, or sinus bradycardia with a heart rate of under than 45 beats per minute, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
  • Subject has lung cancer.
  • Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
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  • Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy.
  • Patient has emphysema of greater than or equal to 50% as quantified on baseline HRCT scan as determined by the CT Core Lab.
  • Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
  • Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
  • Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 2 months.
  • Patient is unable to walk over 225 meters in 6 minutes.
  • Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease, 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).
  • Patient has uncontrolled GERD.
  • Patient has known severe pulmonary hypertension (pulmonary artery SP ≥ 50 mmHg).
  • Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
  • Patient is pregnant, nursing, or planning to get pregnant during study duration.
  • Patient is currently participating in another clinical study involving an investigational product.
  • Patient is receiving anticoagulation for a cardiovascular indication and, in the Primary investigator's opinion, unable to suspend anticoagulant medications (i.e., aspirin, clopidogrel, warfarin) during bronchoscopy in accordance.
  • Patient has known airway colonization with drug-resistant bacteria such as Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Burkholderia cepacia complex, Mycobacterium tuberculosis, Mycobacterium abscessus, Trichoderma, or other significant fungi.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Enguo Chen contact

+86 13588706779

cheneg@srrsh.com

13 sites in 1 country

China13 sites, 13 recruiting

  • Affiliated Beijing Chaoyang Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100020

    Feng Wang

    Feng Wang

    Not yet recruiting

  • Hospital Emergency General

    Beijing, Beijing Municipality, 100028

    Yunzhi Zhou

    Yunzhi Zhou

    Not yet recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

    Chong Li

    Chong Li

    Not yet recruiting

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

    Hangzhou, Zhejiang, 310016

    Enguo Chen, +86 13588706779, cheneg@srrs.com

    Enguo Chen

    Recruiting

  • Anhui Chest Hospital

    Hefei, Anui, 230022

    Ling Xu

    Ling Xu

    Not yet recruiting

  • Jinhua Central Hospital

    Jinhua, Zhejiang, 321000

    Dan Zhu

    Dan Zhu

    Not yet recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

    Weiwen Li

    Weiwen Li

    Not yet recruiting

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330006

    Longhua Sun

    Longhua Sun

    Not yet recruiting

  • Quzhou People's Hospital

    Quzhou, Zhejiang, 324000

    Xuru Jin

    Xuru Jin

    Not yet recruiting

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang, 312000

    Jian Sun

    Jian Sun

    Not yet recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215005

    Zengli Zhang

    Zengli Zhang

    Not yet recruiting

  • The Second People's Hospital of Wuxi

    Wuxi, Jiangsu, 214002

    Xun Wang

    Xun Wang

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

    Bi Chen

    Bi Chen

    Not yet recruiting

Other trials in China

About this study

Official title: A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD

This is a prospective, randomized, parallel group, sham-controlled, multicenter clinical trial. The objective is to evaluate the safety and effectiveness of pulsed electric field ablation system manufactured by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 210 patients will be randomized into the experimental group and the sham group (2:1).

Being tested
Pulse electric field ablation system, Sham Procedure
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.

  • Pulse electric field ablation systemDevice

    Bronchial rheoplasty (BR) is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.

  • Sham ProcedureDevice

    Staged sham procedure: the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient).

Study groups in NCT07068438
Study groupRoleWhat they receive
Pulsed Electric Field Ablation SystemExperimentalNot described
Receives: Device: Pulse electric field ablation system
Sham ProcedureSham comparatorNot described
Receives: Device: Sham Procedure

What is being measured

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

  1. COPD Assessment Test (CAT) Score

    Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden

    Measured: 6 months

Secondary outcomes (9)

  1. COPD Assessment Test (CAT) score

    Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden.

    Measured: 3 and 12 months

  2. COPD Assessment Test (CAT) Score (items 1 and 2)

    Mean change from baseline in mean total scores for items 1 and 2 of the bilateral CAT scores (ranges from 0 to 10), where lower scores represent lower symptom burden.

    Measured: 3, 6 and 12 months

  3. St. George Respiratory Questionnaire (SGRQ-C)

    Change from baseline in the total score of the COPD of the St. George Respiratory Questionnaire (SGRQ-C), the total score ranges from 0 to 100, where lower scores represent lower symptom burden.

    Measured: 6 and 12 months

  4. Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores

    Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores, rated on a scale from 0 to 4, where lower grades represent lower symptom burden.

    Measured: 3, 6 and 12 months

  5. COPD Exacerbations

    Rate of moderate and severe COPD exacerbations.

    Measured: 12 months

  6. Pulmonary Function (FEV1)

    Changes from baseline in forced expiratory volume in the first second (FEV1) during a pulmonary function test (PFT).

    Measured: 3, 6 and 12 months

  7. Pulmonary Function (FEV1 /FVC ratio)

    Changes from baseline in the FEV1 /FVC ratio during a pulmonary function test (PFT).

    Measured: 3, 6 and 12 months

  8. The six minute walking test (6MWT)

    Change from baseline in the 6-minute walk test.

    Measured: 6 and 12 months

  9. Technical success rate

    Success defined as:

    • Experimental group: Successful placement of the device, successful discharge, and successful withdrawal.
    • Control group: Successful placement of the device, and successful withdrawal.

    Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%.

    Measured: Approximately 15-minutes after device removal

Timeline

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

  1. First posted16 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Feb 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07068438
Sponsor's protocol ID
COPD 1.0
Status last verified
Aug 2025
First submitted
23 Jun 2025
Last updated
2 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulse electric field ablation system in people with Chronic Bronchitis and COPD (Chronic Obstructive Pulmonary Disease), run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 13 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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Enguo Chen (+86 13588706779, cheneg@srrsh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COPD Assessment Test (CAT) Score (time frame: 6 months). 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 NCT07068438.

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 2 Sep 2025.

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