ClinicalTrials.gg
RecruitingNCT06629558Updated May 29, 2025

Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema

An interventional study of Silver Nitrate and Nano-silver nitrate in Bronchoscopic Lung Volume Reduction, sponsored by Mansoura University Hospital. Recruiting at 1 site in Egypt. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Mansoura University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

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.

Read the detailed description

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.

Chemical lung volume reduction is an endo-bronchial approach, which uses chemical agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. Endobronchial Valves (EBVs) show an overall success rate of 70-80% in reducing lung volume and improving lung function. Lung volume reduction coils (LVRC-Coils) have a success rate of 50-60%.

Bronchoscopic lung volume reduction with silver nitrate as a chemical agent was used in previous studies using a concentration of 0.5% and showed significant improvement in forced expiratory volume in first second (FEV1), diffusion capacity of lung to carbon monoxide (DLCo), modified Medical Research Council (mMRC) score when compared to base line values and reduction of the High Resolution Computed Tomography (HRCT) volumetry of the emphysematous regions.

Silver nanoparticles (AgNPs) are the most widely used nanomaterial today. These have found a wide range of applications in various areas such as textiles, agriculture, renewable energy, food, catalysis, bioremediation, and biomedicine

02

Conditions studied

  • Bronchoscopic Lung Volume Reduction

Keywords

  • bronchoscopic lung volume reduction
  • Nano-silver nitrate
  • Localized Emphysema
  • Silver nitrate
03

In context

Lead sponsor

Mansoura University Hospital is the lead sponsor of 50 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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: 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

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.
  • > 60%.
  • Current smoker.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    0.5%w/v Nano- silver nitrate solution

    0.5% weight by volume(w/v) Nano- silver nitrate solution for bronchoscopic lung volume reduction in management of localized emphysema

    Drug: Nano-silver nitrate · Device: Bronchoscopic lung volume reduction

  • Active comparator
    0.5%w/v silver nitrate solution

    0.5%w/v silver nitrate solution for bronchoscopic lung volume reduction in management of localized emphysema

    Drug: Silver Nitrate · Device: Bronchoscopic lung volume reduction

Interventions

  • bronchoscopic lung volume reduction in management of localized emphysema

    Also known as: 0.5% w/v Silver nitrate solution

  • DrugNano-silver nitrate

    bronchoscopic lung volume reduction in management of localized emphysema

    Also known as: 0.5% w/v Nano-silver nitrate solution

  • DeviceBronchoscopic lung volume reduction

    bronchoscopic lung volume reduction in management of localized emphysema

    Also known as: Bronchoscopy

06

What researchers measure

Primary outcomes

  1. Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry

    RV/TLC ratio measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in RV/TLC and from baseline.

    Time frame: 6 months

  2. change in Forced expiratory volume at first second (FEV1) and Forced vital capacity (FVC)

    change from baseline to 6 months in FEV1 and FVC,

    Time frame: 6 months

  3. Voluometry

    Voluometry measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in voluometry and from baseline.

    Time frame: 6 months

  4. diffusing capacity of the lung for carbon monoxide (DLCO)

    change from baseline to 6 months in diffusing capacity of the lung for carbon monoxide (DLCO)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Mohamed AbdElmoniem
    Mansoura, 35516, Egypt
    Recruiting
    • Mohamed AbdElmoniem · Contactdr.m1993@mans.edu.eg · 01014008473
    • Mahamoud Elhosiny · Contactdr.m1993@mans.edu.eg · 01014008473
    • Mohammad Khairy El-Badrawy · Sub investigator
    • Mahmoud Mostafa Elhosiny · Sub investigator
    • Farid Abd-Elreheim Badria · Sub investigator
    • Nihal Magdy El Batouty · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06629558
Lead sponsor
Mansoura University Hospital
Responsible party
Mohamed Abd Elmoniem Mohamed (Lecturer of chest medicine, Mansoura University Hospital) — Principal investigator
First posted
Oct 8, 2024
Start date
Oct 1, 2024
Primary completion
Dec 1, 2025 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
May 29, 2025

Study contacts

Mohamed AbdElmoniem
Contact
dr.m1993@mans.edu.eg
01014008473
Mohamed AbdElmoniem
principal investigator · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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