Bronchoscopic Lung Volume Reduction Using Blood
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01528267|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : December 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Emphysema||Other: Autologous blood Other: Normal saline||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomised, Double Blind, Sham Controlled Trial of Autologous Blood Lung Volume Reduction|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Active Comparator: Autologous blood
Patients will have 50mls of autologous blood injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.
Other: Autologous blood
50mls of autologous blood injected into each of 3 bronchopulmonary segments.
Sham Comparator: Saline
Patients will have 50mls of normal saline injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.
Other: Normal saline
50mls of normal saline injected into each of 3 bronchopulmonary segments.
- Evidence of scarring and volume loss on CT scanning [ Time Frame: 6 weeks ]
- To ensure no significant lung function deteriorations at 6 weeks post-procedure [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528267
|Chelsea and Westminster NHS Foundation Trust|
|London, United Kingdom|
|Principal Investigator:||Pallav Shah, MBBS, MD||Chelsea and Westminster Hospital NHS Foundation Trust|