Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2025-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study is a multicenter, prospective local medical device clinical trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Broncho Muco Cleaner

Intervention Type DEVICE

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.

Interventions

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Broncho Muco Cleaner

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No