CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
PSD Veritas Collagen Matrix +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00566943
NCT00566943N/ACompleted
CompareCT.gov

Synovis Life Technologies, Inc., Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement. The RESULTS Trial

Baxter Healthcare Corporation·interventional·Posted Dec 4, 2007·Updated May 19, 2017

In Brief

A clinical study evaluating PSD Veritas Collagen Matrix and Roux-en-Y gastric by-pass surgery with no buttress for Obesity. Completed, enrolled 101 participants across 1 site.

Detailed Summary

The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
CollaboratorsSynovis Surgical Innovations

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2007
Enrollment StartMar 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.6 years ago

Interventions

PSD Veritas Collagen Matrixdevice

Roux-en-Y gastric by-pass surgery. Surgeon creates a small pouch from the stomach and then by-passes a large portion of the small intestine. The body cannot absorb as many calories or nutrients thus resulting in weight loss.

Roux-en-Y gastric by-pass surgery with no buttressprocedure

Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple line including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine intestine to mesentery.