Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Heidelberg.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01357460
First received: May 16, 2011
Last updated: May 19, 2011
Last verified: May 2011
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| First Received Date ICMJE | May 16, 2011 | ||||||||
| Last Updated Date | May 19, 2011 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity) [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01357460 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency | ||||||||
| Official Title ICMJE | Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency | ||||||||
| Brief Summary | Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hereditary Emphysema (Alpha 1-antitrypsin Deficiency) | ||||||||
| Intervention ICMJE | Device: Implantation 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.
Other Name: Spiration IBV |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | May 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01357460 | ||||||||
| Other Study ID Numbers ICMJE | Protocol D2.0 - 31.08.2010 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Thoraxklinnik Heidelberg, Thoraxklinik Heidelberg | ||||||||
| Study Sponsor ICMJE | University of Heidelberg | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Heidelberg | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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