Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-predominant COPD Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Clinodevice
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Quality of Life for the device
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Quality of Life for the device
时间窗: 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 - 6 min walking test
时间窗: 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 - St George Respiratory Questionnaire
时间窗: 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 - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)
时间窗: 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
时间窗: 52 weeks
Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.
Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Improvement in functional parameters - 6 Minute Walk Test (V1-V6)(52 weeks)
- Adverse events(52 weeks)
- Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)(52 weeks)
- Changes in laboratory test results(52 weeks)