Suspended

Evaluation of Endobronchial Coil System for Emphysema Symptom Relief

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Study Aim

This study aims to observe how an Endobronchial Coil System can potentially improve your quality of life if you are living with emphysema.

What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

+ Emphysema

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2013
See protocol details

Summary

Principal SponsorBoston Scientific Corporation
Last updated: July 16, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

This study is a multi-center registry, designed to observe and gather information about the experiences of patients with emphysema who are using a specific endobronchial coil system for symptom relief. The focus is on individuals who have already received the CE Mark product, a special certification for medical devices in the European market. The main goal of this study is to understand how effective and safe this system is in real-world use, potentially paving the way for improved care and management of emphysema symptoms. Participants in this study will have their quality of life (QOL) measures recorded over time to evaluate changes. The endobronchial coil system is a treatment that is inserted into the lungs to help reduce symptoms of emphysema. The study aims to understand how this system impacts the daily life and overall well-being of the patients. By monitoring these changes, the study hopes to provide valuable insights into the effectiveness and safety of this treatment approach.

Principal SponsorBoston Scientific Corporation
Last updated: July 16, 2021
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

1275 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmphysema

Criteria

Inclusion and exclusion criteria in the Registry are based on CE Mark approved indication and approved Instructions for Use. Patients enrolled and treated in the Registry study should meet the requirements of the PneumRx Endobronchial Coil System Instructions for Use.

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

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 73 locations

Otto-Wagner-Spital

Vienna, AustriaOpen Otto-Wagner-Spital in Google Maps

Rigshospitalet Copenhaven

Copenhagen, Denmark

Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie

Bad Homburg, Germany

Charité Campus Mitte

Berlin, Germany
Suspended73 Study Centers