Synovis Life Technologies, Inc., Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement. The RESULTS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.
研究概览
简要总结
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.
时间窗: 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.
Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.
时间窗: 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.
次要结局
- 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)