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Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy (EXERTION)

Primary Purpose

COPD

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Broncho Muco Cleaner
Sponsored by
Clinodevice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COPD focused on measuring Chronic Bronchitis, Medical Device, Baloon Dilatation

Eligibility Criteria

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

Inclusion Criteria: Adults of both sexes aged 40-75 years Being diagnosed with stage II-IV chronic bronchitis-predominant COPD according to the GOLD guideline To have quit smoking for at least 6 months mMRC 2 and above Receiving optimal medical treatment for COPD Being stable for at least 3 weeks To have completed 6 weeks of pulmonary rehabilitation before the first procedure Having sufficient mental and physical capacity to sign the voluntary consent form for the procedure. Exclusion Criteria: be under the age of 40 and over the age of 75 pregnant patients breastfeeding a child Being an active smoker Concurrent asthma Chronic kidney disease with GFR <30 ml/min Clinically significant arrhythmia, Left heart failure (EF<45) or pulmonary hypertension (PABs>45 mmHg) Liver cirrhosis Those who use anticoagulants or clopidogrel or equivalent drugs and cannot be stopped before and during the procedure, or the presence of bleeding diathesis 6 minutes walking test <100 meters FEV1<15% Those with positive early reversibility in pulmonary function tests Patients who do not regularly take 15lgu15in therapy for COPD Emphysema-predominant COPD patients Presence of active malignancy Partial CO2 pressure > 55mmHg or pO2<55 mmHg in room air Active pulmonary infection Pneumothorax or pulmonary surgery in the last 6 months Patients with other clinically significant lung disease other than COPD Those who have undergone a previous lung device procedure, including implanted emphysema stents, lung coil delivery, valves, lung denervation, or other devices for emphysema. Those taking > 10 mg of prednisolone per day Those with a known sensitivity to the drug (such as lidocaine, 15lgu15ine and benzodiazepines) needed to perform bronchoscopy.

Sites / Locations

  • Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Broncho Muco Cleaner

Arm Description

It will be applied to patients with a diagnosis of chronic bronchitis-predominant COPD, who cannot achieve adequate clinical and functional improvement despite optimal medical therapy. In patients who meet the patient selection criteria, anesthesia approval will be obtained before the procedure will be performed under general anesthesia

Outcomes

Primary Outcome Measures

Reliability of the procedure - Safety
Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.
Patients' Tolerence - mMRC dyspnea scale
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. Primary evaluation criteria in determining the Processing efficiency of your device.
Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device
Patients' Tolerence - St George Respiratory Questionnaire
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.
Patients' Tolerence - 6 min walking test
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.
Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.
Detection of Execerbations
COPD Exacerbation (COPD Exacerbation) is one of the most important problems of COPD patients and includes the risk of mortality and mirdit. It is expected that the number of exacerbations of the patients will decrease with the broncho muco cleaner balloon treatment. The number and severity of exacerbations (mild, moderate, severe) at each visit of the patient will be noted to assess the effect of treatment on exacerbations.
Quality of Life for the device
A St George quality of life survey will be conducted and recorded. Every 4-point change in the SGRQ questionnaire will be considered minimal clinical significance.

Secondary Outcome Measures

Improvement in functional parameters - 6 Minute Walk Test (V1-V6)
- 6 Minute Walk Test (V1-V6)
Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
- Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
Adverse events
Adverse events seen (AE)
Changes in laboratory test results
Change in blood chemistry tests and hemogramcompared to baseline and EoT

Full Information

First Posted
February 24, 2022
Last Updated
May 11, 2023
Sponsor
Clinodevice
Collaborators
Klinar CRO
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1. Study Identification

Unique Protocol Identification Number
NCT05868941
Brief Title
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
Acronym
EXERTION
Official Title
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-predominant COPD Cases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinodevice
Collaborators
Klinar CRO

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
In COPD patients with chronic bronchitis, it is aimed to determine whether the broncho muco cleaner balloon dilation method can provide clinical and functional benefit by causing destruction in hyperplasic goblet cells in the bronchial system. Although 2 studies have been published on this subject before, one of them is a retrospective design and the other is a pilot study consisting of only 10 patients . Therefore, it is clear that it should be supported by a controlled prospective study with more patients. Within the scope of the research, broncho muco cleaner balloon dilatation treatment will be performed with fiberoptic bronchoscope under general anesthesia in chronic bronchitis-predominant COPD cases, and the effectiveness and reliability of the procedure will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Chronic Bronchitis, Medical Device, Baloon Dilatation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a multicenter, prospective local medical device clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Broncho Muco Cleaner
Arm Type
Experimental
Arm Description
It will be applied to patients with a diagnosis of chronic bronchitis-predominant COPD, who cannot achieve adequate clinical and functional improvement despite optimal medical therapy. In patients who meet the patient selection criteria, anesthesia approval will be obtained before the procedure will be performed under general anesthesia
Intervention Type
Device
Intervention Name(s)
Broncho Muco Cleaner
Intervention Description
The endotracheal tube will be passed with a bronchoscope. During the procedure, the product is connected to the oxygen jack in the hospital, inflated and deflated, turning the thickened goblet cell layer that causes sputum production to foamy liquid. For the procedure, it will be entered through the intubation tube with a fiberoptic bronchoscope, and the airways with a diameter of 3 to 8 mm, primarily the airways, and all the respiratory tract mucosa that can be reached will be treated with a balloon in a total of 3 sessions. For these procedures, balloons selected in accordance with the diameter of the bronchi will be used in the respiratory tract. In patients who meet the patient selection criteria, intervention will be made with a balloon that inflates and deflates at the determined frequency and pressure from the subsegment level that can be reached with the bronchoscope to the inner surface of the airways proximally.
Primary Outcome Measure Information:
Title
Reliability of the procedure - Safety
Description
Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.
Time Frame
52 weeks
Title
Patients' Tolerence - mMRC dyspnea scale
Description
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. Primary evaluation criteria in determining the Processing efficiency of your device.
Time Frame
52 Weeks
Title
Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)
Description
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device
Time Frame
52 Weeks
Title
Patients' Tolerence - St George Respiratory Questionnaire
Description
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.
Time Frame
52 Weeks
Title
Patients' Tolerence - 6 min walking test
Description
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.
Time Frame
52 Weeks
Title
Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)
Description
Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.
Time Frame
52 Weeks
Title
Detection of Execerbations
Description
COPD Exacerbation (COPD Exacerbation) is one of the most important problems of COPD patients and includes the risk of mortality and mirdit. It is expected that the number of exacerbations of the patients will decrease with the broncho muco cleaner balloon treatment. The number and severity of exacerbations (mild, moderate, severe) at each visit of the patient will be noted to assess the effect of treatment on exacerbations.
Time Frame
52 weeks
Title
Quality of Life for the device
Description
A St George quality of life survey will be conducted and recorded. Every 4-point change in the SGRQ questionnaire will be considered minimal clinical significance.
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Improvement in functional parameters - 6 Minute Walk Test (V1-V6)
Description
- 6 Minute Walk Test (V1-V6)
Time Frame
52 weeks
Title
Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
Description
- Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
Time Frame
52 weeks
Title
Adverse events
Description
Adverse events seen (AE)
Time Frame
52 weeks
Title
Changes in laboratory test results
Description
Change in blood chemistry tests and hemogramcompared to baseline and EoT
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults of both sexes aged 40-75 years Being diagnosed with stage II-IV chronic bronchitis-predominant COPD according to the GOLD guideline To have quit smoking for at least 6 months mMRC 2 and above Receiving optimal medical treatment for COPD Being stable for at least 3 weeks To have completed 6 weeks of pulmonary rehabilitation before the first procedure Having sufficient mental and physical capacity to sign the voluntary consent form for the procedure. Exclusion Criteria: be under the age of 40 and over the age of 75 pregnant patients breastfeeding a child Being an active smoker Concurrent asthma Chronic kidney disease with GFR <30 ml/min Clinically significant arrhythmia, Left heart failure (EF<45) or pulmonary hypertension (PABs>45 mmHg) Liver cirrhosis Those who use anticoagulants or clopidogrel or equivalent drugs and cannot be stopped before and during the procedure, or the presence of bleeding diathesis 6 minutes walking test <100 meters FEV1<15% Those with positive early reversibility in pulmonary function tests Patients who do not regularly take 15lgu15in therapy for COPD Emphysema-predominant COPD patients Presence of active malignancy Partial CO2 pressure > 55mmHg or pO2<55 mmHg in room air Active pulmonary infection Pneumothorax or pulmonary surgery in the last 6 months Patients with other clinically significant lung disease other than COPD Those who have undergone a previous lung device procedure, including implanted emphysema stents, lung coil delivery, valves, lung denervation, or other devices for emphysema. Those taking > 10 mg of prednisolone per day Those with a known sensitivity to the drug (such as lidocaine, 15lgu15ine and benzodiazepines) needed to perform bronchoscopy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuba Kılıç
Phone
90 533 730 90 28
Email
tubak@klinar-cro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erdogan Cetinkaya
Organizational Affiliation
stanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erdoğan Çetinkaya
First Name & Middle Initial & Last Name & Degree
Erdogan Cetinkaya
First Name & Middle Initial & Last Name & Degree
Mustafa Cortük

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy

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