Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811833
Status:
WITHDRAWN
Last Update Posted:
2023-04-05
First Post:
2021-03-17
Brief Title:
Gastrointestinal Anastomosis Using MonoPlus Suture
Sponsor:
Aesculap AG
Organization:
Aesculap AG
Study Overview
Official Title:
Assessment of MonoPlus Suture Material for Anastomosis in the Gastrointestinal Tract A Prospective Multi-centric International Single-arm Observational Study in Daily Practice
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The GASTROMO study has been stopped early before enrolling its first patient because the results of our primary endpoint would have been inconsistent The variability of the leakage rate between all anastomosis included in the study was overly high
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GASTROMO
Brief Summary:
The primary aim of this study is to collect clinical data on the performance of MonoPlus suture applied in routine clinical practice Diverse parameters are to be used to assess the safety and efficacy of MonoPlus suture for gastrointestinal anastomosis construction
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up PMCF activity
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up PMCF activity
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