Clinical Trials Directory

Trials / Terminated

TerminatedNCT01357460

Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Heidelberg University · Academic / Other
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

Summary

Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.

Detailed description

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.

Conditions

Interventions

TypeNameDescription
DEVICEImplantation of intrabronchial valves (IBV) (Spiration IBV)In advanced emphysema due to alpha1 antitrypsin deficiency even optimum treatment including drugs, physical training and possibly oxygen therapy is unable to influence exercise dyspnoea and exercise capacity.Implantation of intrabronchial valves in the most destroyed and hyperinflated lung lobe can improve the elastic recoil of the small airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function.The one-way mechanism of these valves allows air to escape from the downstream lung segment without any influx of "new" air during inspiration.

Timeline

Start date
2011-05-01
Primary completion
2014-09-24
Completion
2014-12-30
First posted
2011-05-20
Last updated
2022-08-30

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01357460. Inclusion in this directory is not an endorsement.