An interventional study of Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in Chronic Bronchitis, sponsored by Jiayuan Sun. Status unknown at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Jiayuan Sun · Not applicable, Interventional, and Treatment
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.
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.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's planned enrollment of 15 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →Jiayuan Sun is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Within 30 days after either the first or second study procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: After bilateral treatment, assessed up to 2 months
Plan to share: No
Start is estimated for Mar 2023; primary completion for Mar 2024, 12 months later.
Of 24 interventional studies with no phase under Bronchitis, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 47. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Jiayuan Sun