Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555276
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
Status:
NOT_YET_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:
This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection transection and anastomosis
Detailed Description:
The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co Ltd can be used in open or endoscopic surgery of lung bronchial tissue stomach and intestine resection transection and anastomosis They have been registered in China for many years and have been widely used and have been certified by the European Union in 2021 The number is CIM202110614629 This study intends to conduct a multi-center retrospective cohort study in China collect clinical application data of Chinese patients conduct statistical analysis on the clinical application data confirm whether the expected effectiveness and safety are achieved and further extrapolate to the EU population
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