Bronchoscopic Lung Volume Reduction Using Blood
|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 ]
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|