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US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation

2014-07-23 21:52:00 | BioPortfolio

Summary

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Description

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.

Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Emphysema

Intervention

BLVR

Location

Brigham and Women's Hospital
Boston
Massachusetts
United States
02115

Status

Completed

Source

Aeris Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:52:00-0400

Clinical Trials [1089 Associated Clinical Trials listed on BioPortfolio]

Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.

Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.

US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

PubMed Articles [2547 Associated PubMed Articles listed on BioPortfolio]

Quantitative and Qualitative Assessment of Pulmonary Emphysema with T2-Weighted PROPELLER MRI in a High-Risk Population Compared to Low-Dose CT.

 To determine the suitability of T2-weighted PROPELLER MRI for the assessment of pulmonary emphysema.

Predictors of outcome of prematurely born infants with pulmonary interstitial emphysema.

To determine how oxygenation, ventilation efficiency and tidal volume requirements changed with the development of pulmonary interstitial emphysema (PIE) and whether in affected patients a composite g...

Free Desmosine is a Sensitive Marker of Smoke-Induced Emphysema.

While the elastin-specific crosslinks, desmosine and isodesmosine (DID), are increased in blood, urine, and sputum of patients with clinically documented pulmonary emphysema, the usefulness of DID in ...

Pulmonary Emphysema Quantification on Ultra-Low-Dose Computed Tomography Using Model-Based Iterative Reconstruction With or Without Lung Setting.

To evaluate the influence of model-based iterative reconstruction (MBIR) with lung setting and conventional setting on pulmonary emphysema quantification by ultra-low-dose computed tomography (ULDCT) ...

Persistent Pulmonary Interstitial Emphysema.

Medical and Biotech [MESH] Definitions

Enlargement of air spaces distal to the TERMINAL BRONCHIOLES where gas-exchange normally takes place. This is usually due to destruction of the alveolar wall. Pulmonary emphysema can be classified by the location and distribution of the lesions.

A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

Measurement of the volume of gas in the lungs, including that which is trapped in poorly communicating air spaces. It is of particular use in chronic obstructive pulmonary disease and emphysema. (Segen, Dictionary of Modern Medicine, 1992)

A lung with reduced markings on its chest radiograph and increased areas of transradiancy (hyperlucency). A hyperlucent lung is usually associated with pulmonary emphysema or PNEUMOTHORAX.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

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