Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix

Completed · Not applicable

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT00566943

Run by

Baxter Healthcare Corporation

People needed

101

Starts

2006-03-01

Expected to finish

2008-12-01

Last updated by the study team

2017-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient 18 years or older
• Patient willing to comply with follow-up evaluations
• Patient understands nature of procedure and provides informed consent
• Female patient has stated that she is not pregnant and will not become pregnant during trial.

You may not qualify if…

• Patient currently enrolled in another device/drug trial that competes for same patient population
• Patient with short life expectancy (12 months) wherever the cause is not linked to obesity
• BMI is equal or less than 40 and equal to or less than 65
• Patient does not meet National Institute of Health (NIH) criteria for gastric by-pass surgery
• Patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial.
• Patient has known sensitivity to bovine material

Where it is running

• University of Missouri-Columbia — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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