Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 7:26 PM
Study NCT ID:
NCT03968757
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
Sponsor:
Duomed
Organization:
Study Overview
Official Title:
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery: a Monocentric Post-market Observational Study
Status:
COMPLETED
Status Verified Date:
2023-06
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:
None
Brief Summary:
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
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?: