Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
bronchoscopic lung volume reduction surgery using endobronchial valve
Chronic Disease+6
+ Emphysema
+ Lung Diseases
Treatment Study
Summary
Study start date: April 11, 2024
Actual date on which the first participant was enrolled.This study focuses on evaluating a new surgical method for people with chronic obstructive pulmonary disease (COPD) who have a type of condition called emphysema. It aims to see if using specially designed endobronchial valves during a procedure called lung volume reduction surgery can help improve lung function, increase exercise capacity, and reduce symptoms in these patients. Understanding the effectiveness and safety of these valves could offer a new way to manage emphysema, potentially providing relief for those who struggle with breathing difficulties related to this condition. Participants in this study will undergo a procedure where these endobronchial valves are placed into their lungs through a tube inserted via the mouth or nose. The study will monitor participants before the surgery and then at intervals of 3 days, 4 weeks, and 12 weeks afterward to see how their lung function and exercise capacities have changed, as well as to record any side effects from the surgery. This will help determine whether this new approach can be safely and effectively used as a treatment option for those living with emphysema.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 85 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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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 1 location