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

Baxter

Status: Completed

Conditions: Obesity

Treatments: Procedure: Roux-en-Y gastric by-pass surgery with no buttress; Device: PSD Veritas Collagen Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566943

CP1007, Rev C

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

101 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Procedure: Roux-en-Y gastric by-pass surgery with no buttress

PSD Veritas

Experimental group

Description:

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.

Treatment:

Device: PSD Veritas Collagen Matrix