Minimally invasive lung volume reduction for localized emphysema
Efficacy and Safety of 0.5% w/v Nano- Silver Nitrate Versus Silver Nitrate Solution for Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema: Prospective Interventional Randomized Controlled Clinical Trial
NA · Mansoura University Hospital · NCT06629558
This study is testing a new way to treat localized emphysema in COPD patients by using a special technique to reduce lung size and improve breathing.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Mansoura University Hospital (other) |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT06629558 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of bronchoscopic lung volume reduction (BLVR) techniques to treat localized emphysema in patients with chronic obstructive pulmonary disease (COPD). The approach involves the endobronchial delivery of silver nitrate to occlude or ablate emphysematous lung tissue, aiming to reduce lung hyperinflation and improve lung function. Patients eligible for this intervention are those with significant respiratory symptoms despite optimal medical therapy and specific lung function criteria. The study will assess the effectiveness of this chemical agent in enhancing lung capacity and overall patient well-being.
Who should consider this trial
Good fit: Ideal candidates are patients under 75 years old with grade III or IV COPD and localized emphysema who are not suitable for surgical lung volume reduction.
Not a fit: Patients with significant co-morbidities, homogeneous emphysema, or those over 75 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients suffering from localized emphysema.
How similar studies have performed: Previous studies using bronchoscopic lung volume reduction techniques have shown promising results, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * COPD of grade III and IV according to GOLD 2024 staging of COPD with localized (heterogeneous) emphysema as determined by high resolution computerized tomography (HRCT) of the chest with area of destruction \>-950 Hounsfield units (HU) and respiratory symptoms despite optimal medical therapy with the following criteria: Patient less than 75 years of age not candidate for or had refused lung volume reduction surgery but fit for fibro-optic bronchoscope (FOB). Lung volumes criteria: FEV1 less than 60% of predicted value, Residual volume (RV) more than 100% of predicted value, Total lung capacity (TLC) more than 100% of predicted value, 6 MWT of less than 450 meters. Exclusion Criteria: * Significant co-morbidities that limits exercise capacity or prognosis as cardiovascular diseases (heart failure, arrhythmia, ischemic heart disease) and lung cancer. * Patients unfit or refused FOB. * Homogenous emphysema. * More than 75 years of age. * Associated lung fibrosis. * FEV1 \> 60%. * Current smoker.
Where this trial is running
Al Mansurah
- Mohamed AbdElmoniem — Al Mansurah, Egypt (RECRUITING)
Study contacts
- Principal investigator: Mohamed AbdElmoniem — Mansoura University
- Study coordinator: Mohamed AbdElmoniem
- Email: dr.m1993@mans.edu.eg
- Phone: 01014008473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchoscopic Lung Volume Reduction, bronchoscopic lung volume reduction, Nano-silver nitrate, Localized Emphysema, Silver nitrate