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New treatment option for Chronic Bronchitis
Official title Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT07068438
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 80
You may be able to join if
- 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...
- 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 \>...
You likely can't join if
- Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus...
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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.
- 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...
- 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.
- 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...
- 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...
- Patient has known airway colonization with drug-resistant bacteria such as Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Burkholderia cepacia complex, Mycobacterium tuberculosis, Mycobacterium...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anui, China
- Beijing, Beijing Municipality, China
- Changzhou, Jiangsu, China
- Suzhou, Jiangsu, China
- Wuxi, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Hangzhou, Zhejiang, China
- Jinhua, Zhejiang, China
- Lishui, Zhejiang, China
- Quzhou, Zhejiang, China
- Shaoxing, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anui, China; Beijing, Beijing Municipality, China; Changzhou, Jiangsu, China; Suzhou, Jiangsu, China; Wuxi, Jiangsu, China; Xuzhou, Jiangsu, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.