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

NCT ID: NCT00566943

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-12-31

Brief Summary

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

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

PSD Veritas

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.

Group Type: EXPERIMENTAL

PSD Veritas Collagen Matrix

Intervention Type: DEVICE

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.

Interventions

PSD Veritas Collagen Matrix

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.

Intervention Type: DEVICE

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

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synovis Surgical Innovations

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger De La Torre, MD

Role: PRINCIPAL_INVESTIGATOR

Division of General Surgery University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

Other Identifiers

CP1007, Rev C

Identifier Type: -

Identifier Source: org_study_id