Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema

NCT06629558 | Recruiting

• 1 other identifier: R.24.09.2776
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchoscopic Lung Volume Reduction

Keywords

bronchoscopic lung volume reduction; Nano-silver nitrate; Localized Emphysema; Silver nitrate

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

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

  change from baseline to 6 months in FEV1 and FVC,

  6 months

• Voluometry

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

  6 months

• 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)

  6 months

Study Arms (2)

0.5%w/v Nano- silver nitrate solution

ACTIVE COMPARATOR

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

0.5%w/v silver nitrate solution

ACTIVE COMPARATOR

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

Silver Nitrate DRUG

bronchoscopic lung volume reduction in management of localized emphysema

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

0.5%w/v silver nitrate solution

Nano-silver nitrate DRUG

bronchoscopic lung volume reduction in management of localized emphysema

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

0.5%w/v Nano- silver nitrate solution

Bronchoscopic lung volume reduction DEVICE

bronchoscopic lung volume reduction in management of localized emphysema

Also known as: Bronchoscopy

0.5%w/v Nano- silver nitrate solution; 0.5%w/v silver nitrate solution

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Silver Nitrate; Pneumonectomy; Bronchoscopy

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures

Study Officials

• Mohamed AbdElmoniem

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AbdElmoniem

CONTACT

01014008473; dr.m1993@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of chest medicine

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

EG (1)