Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
- Conditions
- COPD
- Interventions
- Device: Broncho Muco Cleaner
- Registration Number
- NCT05868941
- Lead Sponsor
- Clinodevice
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Broncho Muco Cleaner Broncho Muco Cleaner 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
- Primary Outcome Measures
Name Time Method Patients' Tolerence - 6 min walking test 52 Weeks 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.
Quality of Life for the device 52 Weeks 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.
Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.) 52 Weeks 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 %) 52 Weeks 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.
Reliability of the procedure - Safety 52 weeks Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.
Patients' Tolerence - St George Respiratory Questionnaire 52 Weeks 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 52 weeks 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.
Patients' Tolerence - mMRC dyspnea scale 52 Weeks 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.
- Secondary Outcome Measures
Name Time Method Improvement in functional parameters - 6 Minute Walk Test (V1-V6) 52 weeks - 6 Minute Walk Test (V1-V6)
Adverse events 52 weeks Adverse events seen (AE)
Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6) 52 weeks - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
Changes in laboratory test results 52 weeks Change in blood chemistry tests and hemogramcompared to baseline and EoT
Trial Locations
- Locations (1)
Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
🇹🇷Istanbul, Turkey