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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: PSD Veritas Collagen Matrix
* Procedure: Roux-en-Y gastric by-pass surgery with no buttress


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple lines including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine). intestine or mesentery. Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without buttress at the GJ anastomosis. Linear buttress at the stomach/pouch staple line is required. | Procedure: Roux-en-Y gastric by-pass surgery with no buttress<br>* 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.<br>|
| Experimental: PSD Veritas<br>Linear Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas used as a staple line buttress at the stomach/pouch. In addition to buttress of the stomach/pouch, patients may have PSD Veritas linear buttress at any of the following staple lines: intestine, mesentery, or anastomosis junction (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine). Circular Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas circular buttress used as a staple line buttress at the GJ anastomosis. Linear buttress at the stomach/pouch is required. | Device: PSD Veritas Collagen Matrix<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. | Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study. | Discharge/ 30 days Linear Discharge/30/90 days Circular | 
| Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group. | Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms. | Discharge/30 Linear Discharge/30/90 days Circular | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group | Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study. | Discharge and 30 days | 
| Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. | Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database. | Discharge, 30 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staple Line Reinforcement, Buttress