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A Clinical Evaluation of the RheOx Bronchial Rheoplasty System

Primary Purpose

Chronic Bronchiolitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RheOx™ with the RheOx™ Catheter treated in the trial
Sponsored by
Energenx Medical LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchiolitis

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject's age is ≥35 years and ≤75 years Subject 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. Subject has a CAT score ≥ 10. 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 a SGRQ score ≥ 25. 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 enrollment. Subject has a cigarette smoking history of at least ten pack years (packs per day x years of smoking), and has had quit smoking for at least 6 months before enrollment; In the opinion of the investigator, subject is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule. Subject has provided informed consent. Exclusion Criteria: Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis). Subject has a pulmonary nodule or cavity . In the judgement of the investigator, the subject may require intervention during the course of the study. Subject has clinically significant bronchiectasis influencing the subject's clinical symptoms of cough and phlegm. Subject has severe other lung diseases (including interstitial pneumonia, lung fibrosis, pulmonary fibrosis with emphysema, atelectasis, unresolved lung Cancer, giant pulmonary bullae); Subject has asthma based on Global Initiative for Asthma (GINA) criteria. Subject has had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation. Subject had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable Subject has a history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, grade II, II or III AV transmission history of conduction blockor, sinus bradycardia with heart rate less than 45 beats per minute. Subject is on anticoagulation for cardiovascular indications and, at the discretion of the investigator, is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for the bronchoscopy procedure per institution's standard of care. * If the anticoagulants withheld is clinically acceptable, five to seven days withheld before enrollment is advised. Subject has other serious diseases (e.g. congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver failure, 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 gastroesophageal reflux disease(GERD)that indicated by the common symptoms and signs like stomach burning, acid reflux, regurgitation of partial digested food or acid into throat. Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices). Subject has known airway colonization with resistant organisms, such as pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus mucor or significant fungus. Subject has known pulmonary hypertension. Subject has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines, Propofol). Subject has known allergy to nickel. Subject is receiving any traditional Chines herbs for cough or phlegm. * mucolytics may be recommended by institute clinical practice, carbocysteine, oral or inhaled N-acetylcysteine, Eucalyptol and ambroxol hydrochloride are suggested. * The treatrment of this study is to ablate bronchial mucosa by airway intervention, then mucosa epithelium is repaired. The effect of inhalation on the repair of airway mucosal epithelium is unknown. Therefore, it is not recommended to oral or inhaled N-acetylcysteine during treatment and follow-up. Subject has a steroid-dependent condition requiring >10 mg of oral corticosteroid (e.g. prednisone or equivalence.) per day. Subject is unable to walk over 225 meters in 6 minutes. Subject has emphysema of greater than or equal to 25% (low attenuation area≤ -950HU) as determined by HRCT quantitative analysis. Subject is pregnant, nursing, or planning to get pregnant during study duration. Subject has hepatitis B or C virus infection, HIV infection, syphilis infection; Subject is currently participating in another clinical study involving an investigational product. Subject is not suitable for bronchoscopy by the judgement of investigator.

Sites / Locations

  • 1st Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • 2nd Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • 10th People's Hospital of ShanghaiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental device RheOx™ with the RheOx™ Catheter was only used in the trial

Arm Description

All of participants who signed the ICF and meet all of inclution and exclution criterias will be enrolled to experimental arm.

Outcomes

Primary Outcome Measures

COPD Assessment Test (CAT) Score
Mean change from baseline to Month 6 in the COPD Assessment Test (CAT) total score,the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden.

Secondary Outcome Measures

Distal airway volume
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
Total Airway Counts
Change from baseline distal airway volume (DAV) at expiration using HRCT scans

Full Information

First Posted
November 17, 2022
Last Updated
May 29, 2023
Sponsor
Energenx Medical LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05641207
Brief Title
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System
Official Title
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Chinese Adult Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Energenx Medical LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test in the Symptoms of Chronic Bronchitis in Chinese Adult Patients with COPD. Participants will be assigned to two sessions of treatments with RheOx Treatment 1 is scheduled at right lung at the first treatment. And then approximately one month later, treatment 2 is delivered to left lung at the second treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An intervention of a device product
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental device RheOx™ with the RheOx™ Catheter was only used in the trial
Arm Type
Experimental
Arm Description
All of participants who signed the ICF and meet all of inclution and exclution criterias will be enrolled to experimental arm.
Intervention Type
Device
Intervention Name(s)
RheOx™ with the RheOx™ Catheter treated in the trial
Intervention Description
Eligible patients will be assigned to two sessions of treatments with RheOx Treatment 1 is scheduled at right lung at the first treatment. And then approximately one month later, treatment 2 is delivered to left lung at the second treatment.
Primary Outcome Measure Information:
Title
COPD Assessment Test (CAT) Score
Description
Mean change from baseline to Month 6 in the COPD Assessment Test (CAT) total score,the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden.
Time Frame
6 Month after procedure
Secondary Outcome Measure Information:
Title
Distal airway volume
Description
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
Time Frame
6 Months
Title
Total Airway Counts
Description
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
Time Frame
Change from baseline total airway counts at expiration using HRCT scans

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject's age is ≥35 years and ≤75 years Subject 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. Subject has a CAT score ≥ 10. 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 a SGRQ score ≥ 25. 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 enrollment. Subject has a cigarette smoking history of at least ten pack years (packs per day x years of smoking), and has had quit smoking for at least 6 months before enrollment; In the opinion of the investigator, subject is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule. Subject has provided informed consent. Exclusion Criteria: Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis). Subject has a pulmonary nodule or cavity . In the judgement of the investigator, the subject may require intervention during the course of the study. Subject has clinically significant bronchiectasis influencing the subject's clinical symptoms of cough and phlegm. Subject has severe other lung diseases (including interstitial pneumonia, lung fibrosis, pulmonary fibrosis with emphysema, atelectasis, unresolved lung Cancer, giant pulmonary bullae); Subject has asthma based on Global Initiative for Asthma (GINA) criteria. Subject has had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation. Subject had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable Subject has a history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, grade II, II or III AV transmission history of conduction blockor, sinus bradycardia with heart rate less than 45 beats per minute. Subject is on anticoagulation for cardiovascular indications and, at the discretion of the investigator, is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for the bronchoscopy procedure per institution's standard of care. * If the anticoagulants withheld is clinically acceptable, five to seven days withheld before enrollment is advised. Subject has other serious diseases (e.g. congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver failure, 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 gastroesophageal reflux disease(GERD)that indicated by the common symptoms and signs like stomach burning, acid reflux, regurgitation of partial digested food or acid into throat. Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices). Subject has known airway colonization with resistant organisms, such as pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus mucor or significant fungus. Subject has known pulmonary hypertension. Subject has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines, Propofol). Subject has known allergy to nickel. Subject is receiving any traditional Chines herbs for cough or phlegm. * mucolytics may be recommended by institute clinical practice, carbocysteine, oral or inhaled N-acetylcysteine, Eucalyptol and ambroxol hydrochloride are suggested. * The treatrment of this study is to ablate bronchial mucosa by airway intervention, then mucosa epithelium is repaired. The effect of inhalation on the repair of airway mucosal epithelium is unknown. Therefore, it is not recommended to oral or inhaled N-acetylcysteine during treatment and follow-up. Subject has a steroid-dependent condition requiring >10 mg of oral corticosteroid (e.g. prednisone or equivalence.) per day. Subject is unable to walk over 225 meters in 6 minutes. Subject has emphysema of greater than or equal to 25% (low attenuation area≤ -950HU) as determined by HRCT quantitative analysis. Subject is pregnant, nursing, or planning to get pregnant during study duration. Subject has hepatitis B or C virus infection, HIV infection, syphilis infection; Subject is currently participating in another clinical study involving an investigational product. Subject is not suitable for bronchoscopy by the judgement of investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Shaoyu, Master
Phone
+86 18910093103
Email
Shaoyu.Yang@energenxmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Guangfa, Doctor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Shiyue, MD
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pan Pinhua, MD
Facility Name
2nd Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Daoxin, MD
Facility Name
10th People's Hospital of Shanghai
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Changhui, MD

12. IPD Sharing Statement

Learn more about this trial

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System

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