Feasibility Study of the Pulsed Electric Field Ablation System in Treating Chronic Bronchitis

NCT05771129 | Unknown DMC

• 1 other identifier: LS22097
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Bronchitis

Keywords

Chronic Bronchitis; Chronic Obstructive Pulmonary Disease; Pulsed Electric Field Ablation; Safety Evaluation; Feasibility Study

Outcome Measures

Primary Outcomes (1)

• To evaluate the rate of adverse events and severe adverse events associated with pulsed electric field ablation systems

  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.

  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)

  6 and 12 months after bilateral treatment

• Improvements in COPD Assessment Test (CAT) score

  6 and 12 months after bilateral treatment

• Clinical Efficacy - Pulmonary Function

  6 and 12 months after bilateral treatment

• Pathological examination-goblet cell proliferation score

  3 months after treatment on the right side

• Acute exacerbation

  12 months after bilateral treatment

Study Arms (1)

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.

Device: Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.

Interventions

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.

Pulsed Electric Field Ablation System was used in treating chronic bronchitis

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 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Jiayuan Sun: lead
• Zhouling (Shanghai) Medical Appliance Co., Ltd.: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 33472961 BACKGROUND

• Herth 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.

  PMID: 35649430 BACKGROUND

• Valipour 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.

  PMID: 32407638 BACKGROUND

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

• Jiayuan Sun, MD., PhD.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, MD., PhD.

CONTACT

86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Endoscopy

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 16, 2023
• Study Start: March 10, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)