NCT05868941Completed
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-predominant COPD Cases
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 24 Feb 2022
- Start date
- 2 Feb 2022
- Primary completion date
- 17 Mar 2025
- Lead sponsor
- Clinodevice
- Diseases
- COPD
- NCT number
- NCT05868941
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 2 Feb 2022 to the primary completion date, 17 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent asthma
- Patients who do not regularly take 15lgu15in therapy for COPD
- Pneumothorax or pulmonary surgery in the last 6 months
- 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 with a known sensitivity to the drug (such as lidocaine, 15lgu15ine and benzodiazepines) needed to perform bronchoscopy.
Other illness
- Clinically significant arrhythmia, Left heart failure (EF\<45) or pulmonary hypertension (PABs\>45 mmHg)
- Those who use anticoagulants or clopidogrel or equivalent drugs and cannot be stopped before and during the procedure, or the presence of bleeding diathesis
- Presence of active malignancy
- Active pulmonary infection
- Patients with other clinically significant lung disease other than COPD
Lab values
- Chronic kidney disease with GFR \<30 ml/min
Age
- be under the age of 40 and over the age of 75
Other
- pregnant patients
- breastfeeding a child
- Being an active smoker
- Liver cirrhosis
- 6 minutes walking test \<100 meters
- FEV1\<15%
- Those with positive early reversibility in pulmonary function tests
- Emphysema-predominant COPD patients
- Partial CO2 pressure \> 55mmHg or pO2\<55 mmHg in room air
- Those taking \> 10 mg of prednisolone per day
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.