N/A
N=101
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00566943 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PSD Veritas Collagen Matrix (Device); Roux-en-Y gastric by-pass surgery with no buttress (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. |
3; 2 | — |
| PRIMARY Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group. |
0; 2 | — |
| SECONDARY Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group |
10; 6 | — |
| SECONDARY Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. |
1; 3 | — |
Summary
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
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
Data sourced from ClinicalTrials.gov (NCT00566943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.