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

NCT00566943 | Completed Results

• 1 other identifier: CP1007, Rev C
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Staple Line Reinforcement, Buttress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group

  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.

  Discharge, 30 and 90 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

PSD Veritas

EXPERIMENTAL

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

Interventions

PSD Veritas Collagen Matrix 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.

PSD Veritas

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Synovis Surgical Innovations: collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lesa Hobright-Turner, Director Clinical Affairs
• Organization: Synovis Surgical Innovations

lesa.hobrightturner@synovissurgical.com

651-796-7506

Study Officials

• Roger De La Torre, MD

  Division of General Surgery University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 4, 2007
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 19, 2017
• Results First Posted: May 28, 2012

Record last verified: 2011-07

Locations

US (1)