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Clinical Trials in Egypt / NCT06629558
Recruiting Not applicable

Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema

NCT06629558 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mansoura University Hospital
Phase
Not applicable
Started
2024-10-01
Last updated
2025-05-29

Condition(s) studied

Bronchoscopic Lung Volume Reduction

Investigational drug(s) / intervention(s)

Silver NitrateNano-silver nitrateBronchoscopic lung volume reduction

Silver Nitrate: bronchoscopic lung volume reduction in management of localized emphysema

Nano-silver nitrate: bronchoscopic lung volume reduction in management of localized emphysema

Bronchoscopic lung volume reduction: bronchoscopic lung volume reduction in management of localized emphysema

Study summary

Emphysema is a progressive phenotype of chronic Obstructive Pulmonary Disease (COPD), poses a significant global health burden characterized by irreversible lung parenchymal destruction and airspace enlargement.

In recent years, bronchoscopic lung volume reduction (BLVR) has considerable interest as a minimally invasive approach to reducing hyperinflation and improving lung function in patients with emphysema.

BLVR techniques aim to achieve lung volume reduction by occluding or ablating emphysematous lung tissue through endobronchial delivery of various agents. Many techniques are available for BLVR as coil, endo-bronchial valve, and biological as thrombin, autologous blood and chemicals as silver nitrate solution.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry — 6 months
    RV/TLC ratio measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in RV/TLC and from baseline.
  • change in Forced expiratory volume at first second (FEV1) and Forced vital capacity (FVC) — 6 months
    change from baseline to 6 months in FEV1 and FVC,
  • Voluometry — 6 months
    Voluometry measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in voluometry and from baseline.
  • diffusing capacity of the lung for carbon monoxide (DLCO) — 6 months
    change from baseline to 6 months in diffusing capacity of the lung for carbon monoxide (DLCO)

Trial sites (1)

FacilityCityRegionStatus
Mohamed AbdElmoniem Al Mansurah Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06629558 on ClinicalTrials.gov ↗ ← All trials in Egypt