Chronic BronchitisNCT05771129
Feasibility Study of the Pulsed Electric Field Ablation System in Treating Chronic Bronchitis
A study testing Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in people with Chronic Bronchitis, run by Jiayuan Sun at 1 site in China.
Trial summary
To preliminarily evaluate the safety and feasibility of the pulsed electric field ablation system independently developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in the treatment of chronic bronchitis. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 10 Mar 2025
- 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 at least 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 has a SGRQ score ≥ 25.
- 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 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 randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
- Subject has a cigarette smoking history of at least ten pack years, and has had quit smoking for at least 6 months before enrollment (cigarettes, e-cigarettes, etc.), and agreed to remain non-smoking during the study;
- In the opinion of the investigator, subject is able to undergo 3 bronchoscopies under general anesthesia (including mucosal biopsy), is willing to participate in the study, and is able to follow the study follow-up plan.
Who cannot join
- Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis, etc).
- Subject has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
- Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
- Subject has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
- Subject has unresolved lung cancer.
- Subject has a pulmonary nodule or cavity that in the judgement of the investigator may require intervention during the course of the study.
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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, etc. Previous sub-lobectomy, previous history of pneumothorax but no pneumonectomy, previous pleural disease but no surgical intervention are not the exclusion criteria;
- Subject has emphysema of greater than or equal to 50% as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT.
- Subjects had a history of asthma diagnosed at an age < 30.
- Subject has clinically significant bronchiectasis which clinical symptoms of cough and phlegm affect the subject's quality of life.
- BMI<18 or > 35;
- Subject has a serious medical condition that, in the investigator's opinion, could endanger the patient's life or 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).
- Subject has uncontrolled GERD.
- Subjects are known to have contraindications for bronchoscopy or general anesthesia, or to be allergic to related medications (i.e., lidocaine, atropine, benzodiazepines) and unable to respond to medications.
- Subject is pregnant, nursing, or planning to get pregnant during study duration.
- Subject is currently participating in another clinical study involving an investigational product (with interventional measures).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, MD, PhD, 86-021-22200000 ext. 1511, xkyyjysun@163.com
About this study
Official title: Feasibility and Safety Evaluation of the Pulsed Electric Field Ablation System on Patients With Chronic Bronchitis
To preliminarily evaluate the safety and feasibility of the pulsed electric field ablation system independently developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in the treatment of chronic bronchitis.
Read the detailed description
Pulsed electric field ablation instrument is a therapeutic instrument based on the irreversible electroporation (IRE) mechanism. The high frequency short duration energy is delivered via a disposable pulse ablation catheter through the bronchoscope and act on the bronchial mucosa, through which goblet cell hyperplasia and airway mucus secretion will be alleviated.
The entire treatment consists of two procedure sessions that will be performed one month apart. The first treatment procedure consists of a baseline biopsy of the airway mucosa followed by the treatment of the right lung. The second procedure (one month after right-sided lung treatment) consists of a biopsy of the treated airway, followed by the treatment of the left lung. All procedures will be performed under general anaesthesia. Treatment is considered complete once the two bronchoscopic ablation procedures are successfully completed.
A third bronchoscopy will be performed three months following the first treatment where mucosa-biopsy will be taken from the previously treated airway sites to evaluate the histopathological evidence of change in mucus producing cells within the airway after treatment. Subjects will be required to fill questionnaire (SGRQ and CAT ) and complete several examinations (including chest CT scans, respiratory function tests, etc.) during follow-up.
- Conditions
- Chronic Bronchitis
- Being tested
- Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.
- Keywords
- Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Pulsed Electric Field Ablation, Safety Evaluation, Feasibility Study
- 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 system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.Device
Pulsed electric field ablation instrument is a therapeutic instrument based on the irreversible electroporation (IRE) mechanism. The high frequency short duration energy is delivered via a disposable pulse ablation catheter through the bronchoscope and act on the bronchial mucosa, through which goblet cell hyperplasia and airway mucus secretion will be alleviated. The entire treatment consists of two procedure sessions that will be performed one month apart. The first treatment procedure consists of a baseline biopsy of the airway mucosa followed by the treatment of the right lung. The second procedure consists of a biopsy of the treated airway, followed by the left-side treatment. A third bronchoscopy will be performed three months following the first treatment and mucosa-biopsy will be conducted to evaluate the histopathological change in mucus producing cells after treatment. Subjects will also be required to fill questionnaire and complete several examinations during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electric Field Ablation System was used in treating chronic bronchitis | Experimental | All participants meet inclusion and exclusion criteria and signed the ICF will be enrolled to experimental arm. Receives: Device: Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of adverse events and severe adverse events associated with pulsed electric field ablation systems
- Index Name: Incidence of surgical or device-related adverse events during and within 1 month of bilateral lung ablation Observation purpose: To evaluate the safety of pulsed electric field ablation. Definition of index: To evaluate the adverse events according to CTCAE v5.0 and evaluate its correlation with the device itself or the operation and calculate the incidence rate of serious adverse events related to the device and the operation treatment.
- Index Name: The incidence of surgery-or device-related serious adverse events. Observation purpose: To evaluate the safety of pulsed electric field ablation. Definition of index: To evaluate the serious adverse events according to CTCAE v5.0 and evaluate its correlation with the device itself or the operation and calculate the incidence rate of serious adverse events related to the device and the operation treatment.
Measured: Within 30 days after either the first or second study procedure
Secondary outcomes (7)
Improvements in COPD Version of the St. George Respiratory Questionnaire (SGRQ-C)
To evaluate the changes from baseline in the total score of the COPD Version of the St. George Respiratory Questionnaire (SGRQ-C) at 6 and 12 months after bilateral surgery.
Measured: 6 and 12 months after bilateral treatment
Improvements in COPD Assessment Test (CAT) score
To evaluate changes from baseline in the COPD Assessment Test (CAT) score at 6 and 12 months after bilateral surgery.
Measured: 6 and 12 months after bilateral treatment
Clinical Efficacy - Pulmonary Function
To evaluate changes from baseline in forced expiratory volume in the first second (FEV1) in pulmonary function tests (PFT) at 6 and 12 months after bilateral surgery.
Measured: 6 and 12 months after bilateral treatment
Pathological examination-goblet cell proliferation score
Baseline, 1 month and 3 months after surgery, the mucosa of the right airway should be biopsied, and obtained tissue should be stained with HE and PAS, in which the proliferation of goblet cells should be compared and scored (semi-quantitative , goblet cells: ciliated cells: 0 point, normal, 1: 10; 1 point, mild hyperplasia, 1: 3-10; 2 points, moderate hyperplasia, 1: 1; 3 points, severe hyperplasia, > 1: 1)
Measured: 3 months after treatment on the right side
Acute exacerbation
To evaluate the times of moderate and severe acute exacerbation and the length of hospitalization within 12 months after bilateral operation.
Acute exacerbation is defined as the simultaneous occurrence of two or more exacerbations or new episodes of respiratory symptoms, such as short of breath, cough, expectoration, dyspnea or chest tightness, and at least one respiratory symptom lasts for three days or more, resulting in the need for short-acting bronchodilators, or the use of antibiotics and/or oral glucocorticoids (moderate acute exacerbation), or the need for hospitalization or emergency treatment (severe acute exacerbation)
Measured: 12 months after bilateral treatment
Distal Airway Volume
To evaluate changes from baseline in distal Airway Volume (based on expiratory phase HRCT imaging analysis) at 6 and 12 months after bilateral surgery.
Measured: 6 and 12 months after bilateral treatment
Incidence of device defects
It refers to the unreasonable risks that may endanger human health and life safety in the normal use of medical devices during the clinical trials, such as labeling errors, quality problems, failures, etc.
Measured: After bilateral treatment, assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start10 Mar 2023 (estimated)
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiayuan Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Zhouling (Shanghai) Medical Appliance Co., Ltd.
- Responsible party
- Sponsor-investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD., PhD., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771129
- Sponsor's protocol ID
- LS22097
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartman JE, Garner JL, Shah PL, Slebos DJ. New bronchoscopic treatment modalities for patients with chronic bronchitis. Eur Respir Rev. 2021 Jan 19;30(159):200281. doi: 10.1183/16000617.0281-2020. Print 2021 Mar 31.
PubMed 33472961Herth FJF, Kontogianni K, Brock J. Endoscopic Options for Moderate COPD, Chronic Bronchitis, and Uncontrolled Asthma. Semin Respir Crit Care Med. 2022 Aug;43(4):552-558. doi: 10.1055/s-0042-1747939. Epub 2022 Jun 1.
PubMed 35649430Valipour A, Fernandez-Bussy S, Ing AJ, Steinfort DP, Snell GI, Williamson JP, Saghaie T, Irving LB, Dabscheck EJ, Krimsky WS, Waldstreicher J. Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):681-689. doi: 10.1164/rccm.201908-1546OC.
PubMed 32407638
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety Evaluation of the Pulsed Electric Field Ablation System on Patients With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT05771129
- Acronym / sponsor ID
- LS22097
- Conditions
- Chronic Bronchitis
- Keywords
- Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Pulsed Electric Field Ablation, Safety Evaluation, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jiayuan SunUniversity, hospital or other
- Collaborators
- Zhouling (Shanghai) Medical Appliance Co., Ltd.
- Study start
- 10 Mar 2023 (estimated)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To preliminarily evaluate the safety and feasibility of the pulsed electric field ablation system independently developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in the treatment of chronic bronchitis.
Detailed description
Pulsed electric field ablation instrument is a therapeutic instrument based on the irreversible electroporation (IRE) mechanism. The high frequency short duration energy is delivered via a disposable pulse ablation catheter through the bronchoscope and act on the bronchial mucosa, through which goblet cell hyperplasia and airway mucus secretion will be alleviated.
The entire treatment consists of two procedure sessions that will be performed one month apart. The first treatment procedure consists of a baseline biopsy of the airway mucosa followed by the treatment of the right lung. The second procedure (one month after right-sided lung treatment) consists of a biopsy of the treated airway, followed by the treatment of the left lung. All procedures will be performed under general anaesthesia. Treatment is considered complete once the two bronchoscopic ablation procedures are successfully completed.
A third bronchoscopy will be performed three months following the first treatment where mucosa-biopsy will be taken from the previously treated airway sites to evaluate the histopathological evidence of change in mucus producing cells within the airway after treatment. Subjects will be required to fill questionnaire (SGRQ and CAT ) and complete several examinations (including chest CT scans, respiratory function tests, etc.) during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electric Field Ablation System was used in treating chronic bronchitis | Experimental | Device: Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.All participants meet inclusion and exclusion criteria and signed the ICF will be enrolled to experimental arm. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject's age is ≥35 years and ≤80 years;
- Subject has chronic bronchitis, defined as productive cough for at least 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 has a SGRQ score ≥ 25.
- 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.
Key exclusion criteria (16 listed)
- Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis, etc).
- Subject has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
- Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
- Subject has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
- Subject has unresolved lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.Pulsed electric field ablation instrument is a therapeutic instrument based on the irreversible electroporation (IRE) mechanism. The high frequency short duration energy is delivered via a disposable pulse ablation catheter through the bronchoscope and act on the bronchial mucosa, through which goblet cell hyperplasia and airway mucus secretion will be alleviated. The entire treatment consists of two procedure sessions that will be performed one month apart. The first treatment procedure consists of a baseline biopsy of the airway mucosa followed by the treatment of the right lung. The second procedure consists of a biopsy of the treated airway, followed by the left-side treatment. A third bronchoscopy will be performed three months following the first treatment and mucosa-biopsy will be conducted to evaluate the histopathological change in mucus producing cells after treatment. Subjects will also be required to fill questionnaire and complete several examinations during follow-up. | Device | Pulsed Electric Field Ablation System was used in treating chronic bronchitis |
Primary outcome
To evaluate the rate of adverse events and severe adverse events associated with pulsed electric field ablation systems
Time frame: Within 30 days after either the first or second study procedure
1. Index Name: Incidence of surgical or device-related adverse events during and within 1 month of bilateral lung ablation Observation purpose: To evaluate the safety of pulsed electric field ablation. Definition of index: To evaluate the adverse events according to CTCAE v5.0 and evaluate its correlation with the device itself or the operation and calculate the incidence rate of serious adverse events related to the device and the operation treatment. 2. Index Name: The incidence of surgery-or device-related serious adverse events. Observation purpose: To evaluate the safety of pulsed electric field ablation. Definition of index: To evaluate the serious adverse events according to CTCAE v5.0 and evaluate its correlation with the device itself or the operation and calculate the incidence rate of serious adverse events related to the device and the operation treatment.
7 secondary outcomes
Improvements in COPD Version of the St. George Respiratory Questionnaire (SGRQ-C)
Time frame: 6 and 12 months after bilateral treatment
Improvements in COPD Assessment Test (CAT) score
Time frame: 6 and 12 months after bilateral treatment
Clinical Efficacy - Pulmonary Function
Time frame: 6 and 12 months after bilateral treatment
Pathological examination-goblet cell proliferation score
Time frame: 3 months after treatment on the right side
Acute exacerbation
Time frame: 12 months after bilateral treatment
Distal Airway Volume
Time frame: 6 and 12 months after bilateral treatment
Incidence of device defects
Time frame: After bilateral treatment, assessed up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 33472961Hartman JE, Garner JL, Shah PL, Slebos DJ. New bronchoscopic treatment modalities for patients with chronic bronchitis. Eur Respir Rev. 2021 Jan 19;30(159):200281. doi: 10.1183/16000617.0281-2020. Print 2021 Mar 31.
- Background: PubMed 35649430Herth FJF, Kontogianni K, Brock J. Endoscopic Options for Moderate COPD, Chronic Bronchitis, and Uncontrolled Asthma. Semin Respir Crit Care Med. 2022 Aug;43(4):552-558. doi: 10.1055/s-0042-1747939. Epub 2022 Jun 1.
- Background: PubMed 32407638Valipour A, Fernandez-Bussy S, Ing AJ, Steinfort DP, Snell GI, Williamson JP, Saghaie T, Irving LB, Dabscheck EJ, Krimsky WS, Waldstreicher J. Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):681-689. doi: 10.1164/rccm.201908-1546OC.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayuan Sun, MD., PhD. principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in people with Chronic Bronchitis, run by Jiayuan Sun at 1 site 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 16 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD., PhD. (86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the rate of adverse events and severe adverse events associated with pulsed electric field ablation systems (time frame: Within 30 days after either the first or second study procedure). 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 NCT05771129, which also lists 3 linked publications.
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 16 Mar 2023.