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

April 19, 2017 updated by: Baxter Healthcare Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Experimental: 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.
Device: 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.

What is the study measuring?

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.
Time Frame: Discharge/ 30 days Linear Discharge/30/90 days Circular
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.
Time Frame: Discharge/30 Linear Discharge/30/90 days Circular
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
Time Frame: Discharge and 30 days
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.
Time Frame: Discharge, 30 and 90 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

Synovis Surgical Innovations

Investigators

  • Principal Investigator: Roger De La Torre, MD, Division of General Surgery University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP1007, Rev C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Roux-en-Y gastric by-pass surgery with no buttress

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe