Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515015
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Evaluation of the Feasibility Safety and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Single-Group Single-Center Clinical Study to Evaluate the Feasibility Safety and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Objective To evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy providing domestic experience for the development and clinical application of bronchial occlusion
Study Population Patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax
Sample Size This study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax The sample size has not been strictly calculated and it is expected to include 10 patients
Study Design This study is an exploratory single-group single-center clinical study
Study Population Patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax
Sample Size This study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax The sample size has not been strictly calculated and it is expected to include 10 patients
Study Design This study is an exploratory single-group single-center clinical study
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