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

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

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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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