Ignite Creation Date:
2024-05-05 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00566943
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2007-11-29
Brief Title:
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry PSD With Veritas Collagen Matrix
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
Synovis Life Technologies Inc Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement The RESULTS Trial
Status:
COMPLETED
Status Verified Date:
2011-07
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:
RESULTS
Brief Summary:
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity
Detailed Description:
The purpose of the study is to verify the performance of PSD Veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-Y surgery The study is designed as two separate patient groups One will enroll patients into a group where linear staple lines are buttressed at the stomach The second portion of the trial will enroll patients into a group where the circular staple line at the GJ and linear staple lines at the stomach are buttressed with PSD Veritas
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