Completed

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

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What is being tested

BLVR

Biological
Who is being recruted

Pulmonary Emphysema

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2005

See protocol details

Summary

Principal SponsorAeris Therapeutics
Last updated: March 6, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2005Actual date on which the first participant was enrolled.

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

Official TitlePhase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema 
Principal SponsorAeris Therapeutics
Last updated: March 6, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
6 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pulmonary Emphysema
Criteria

Inclusion Criteria: * Advanced emphysema * Limited exercise capacity and persistent symptoms despite medical therapy * Age between 18 and 75 * No significant heart, kidney or liver disease * Willingness and ability to tolerate bronchoscopy * No prior Lung Volume Reduction Surgery or Lung Transplantation * Screening test results indicating that the procedure is appropriate

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Treatment with BLVR
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Brigham and Women's HospitalBoston, United StatesSee the location
Suspended
Caritas St Elizabeth's Medical CenterBoston, United States
Completed2 Study Centers