Ignite Creation Date:
2024-05-06 @ 2:59 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02179125
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2014-06-25
Brief Title:
Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACTION
Brief Summary:
Rationale The PneumRx RePneu Lung Volume Reduction Coil RePneu LVR-coil is a bronchoscopic lung volume reduction treatment designed to compress the areas of lung parenchyma most damaged by emphysema The LVRC treatment was found to be feasible safe and effective in previous studies However patient-based outcomes besides quality of life questionnaires are hardly measured after intervention treatments for COPD Furthermore the exact underlying physiological mechanism of the LVR-coil treatment is unknown Another aspect of the treatment which we to date do not fully understand is which group of patients benefit of the treatment and which group of patients do not this knowing that the responder rate is already about 60
Objective The objectives of the study are to gain more knowledge on 1 the effect of the LVRC treatment on patient-based outcomes like physical activity 2 the underlying physiological mechanism of the treatment 3 the predictors of response to the treatment at baseline and 4 on a targetted treatment number of coils to be placed per lung using lung compliance
Study design This study is a non-randomised open label multi-center intervention study
Study population The study population exists of adult patients with severe emphysema with no other treatment options left besides surgical procedures
Intervention Bilateral bronchoscopic lung volume reduction treatment with RePneu coils
Main study parametersendpoints The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment The secondary endpoints are the changes between baseline and 3 months follow-up after the second treatment in patient reported outcomes of the treatment dynamic lung hyperinflation static lung volumes lung compliance diaphragm function lung perfusion systemic inflammation and small airways function
Nature and extent of the burden and risks associated with participation benefit and group relatedness The LVR Coil has been designed to be as safe as possible It was shown that the risks associated with the LVRC system are largely attributable to the bronchoscopic procedure itself rather than to the device per se Therefore it appears that the LVRC device itself does not appreciably increase the risk of serious adverse events beyond the risk of undergoing a bronchoscopy procedure or simply having emphysema Currently this treatment is not commercially available in the Netherlands and study participants will have to visit the hospital multiple times Previous studies have shown that the treatment has beneficial effect for the patient however not all patients respond Part of this new study is to try to identify which group of patients respond to the treatment and which patients do not Therefore it is possible that a patient will not receive any benefits from the treatment
Objective The objectives of the study are to gain more knowledge on 1 the effect of the LVRC treatment on patient-based outcomes like physical activity 2 the underlying physiological mechanism of the treatment 3 the predictors of response to the treatment at baseline and 4 on a targetted treatment number of coils to be placed per lung using lung compliance
Study design This study is a non-randomised open label multi-center intervention study
Study population The study population exists of adult patients with severe emphysema with no other treatment options left besides surgical procedures
Intervention Bilateral bronchoscopic lung volume reduction treatment with RePneu coils
Main study parametersendpoints The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment The secondary endpoints are the changes between baseline and 3 months follow-up after the second treatment in patient reported outcomes of the treatment dynamic lung hyperinflation static lung volumes lung compliance diaphragm function lung perfusion systemic inflammation and small airways function
Nature and extent of the burden and risks associated with participation benefit and group relatedness The LVR Coil has been designed to be as safe as possible It was shown that the risks associated with the LVRC system are largely attributable to the bronchoscopic procedure itself rather than to the device per se Therefore it appears that the LVRC device itself does not appreciably increase the risk of serious adverse events beyond the risk of undergoing a bronchoscopy procedure or simply having emphysema Currently this treatment is not commercially available in the Netherlands and study participants will have to visit the hospital multiple times Previous studies have shown that the treatment has beneficial effect for the patient however not all patients respond Part of this new study is to try to identify which group of patients respond to the treatment and which patients do not Therefore it is possible that a patient will not receive any benefits from the treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL4971604214 | OTHER | ABR-Form | None |