Expired Study
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Columbia, Missouri 65212


Purpose:

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


Study summary:

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.


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 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


NCT ID:

NCT00566943


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Columbia, Missouri 65212
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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