Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520152
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2020-08-17
Brief Title:
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT
Status:
COMPLETED
Status Verified Date:
2023-11
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:
EFFORT
Brief Summary:
Patients with severe emphysema have limited options for treatment Current treatments include lung transplant lung volume reduction surgery or endobronchial lung volume reduction using valves or coils These options are only available for a small and selected group of patients The Free Flow Medical Lung Tensioning Device System LTD is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None