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| Name | Class |
|---|---|
| Synovis Surgical Innovations | INDUSTRY |
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The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger De La Torre, MD | Division of General Surgery University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
Subjects were excluded from the study if their Body Mass Index was less than or equal to 35 or greater than or equal to 65. Subjects could not have a life expectancy of less than 12 months nor a known sensitivity to bovine material.
Subjects were recruited at one surgical site in the US from approximately March 2006 through May 2008. One hundred one subjects were entered into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | control arm where no buttress is used on stomach or GJ anastomosis staple lines. |
| FG001 | PSD Veritas | PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | control arm where no buttress is used on stomach or GJ anastomosis staple lines. |
| BG001 | PSD Veritas | PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Participants | Discharge/ 30 days Linear Discharge/30/90 days Circular |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | control arm where no buttress is used on stomach or GJ anastomosis staple lines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lesa Hobright-Turner, Director Clinical Affairs | Synovis Surgical Innovations | 651-796-7506 | lesa.hobrightturner@synovissurgical.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Number | Participants | Discharge/30 Linear Discharge/30/90 days Circular |
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| Secondary | Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group | 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. | Posted | Number | Participants | Discharge and 30 days |
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| Secondary | Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas. | 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. | Posted | Number | participants | Discharge, 30 and 90 days |
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| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | PSD Veritas | PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas. | 0 | 49 | 0 | 49 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |