Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Cost of each closure
研究概览
简要总结
This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.
详细描述
Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects.
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 is greater than or equal to 18 years of age.
- •Patient can provide informed consent.
- •Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
- •Post resection defect > 3cm.
- •Lesion 2cm or greater from the dentate line.
排除标准
- •Patient is < 18 years of age.
- •Patient refused and/or unable to provide consent.
- •Patient is pregnant.
- •Patient is currently incarcerated
研究组 & 干预措施
Through-the-Scope clip group
Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.
干预措施: Closure type (Procedure)
X-Tack suturing group
Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.
干预措施: Closure type (Procedure)
结局指标
主要结局
Cost of each closure
时间窗: Day 1
Total cost amount for equipment used in closure of GI defect
次要结局
- Rate of complete closure of GI defect(Day 1 (end of procedure))
- Successful Tissue approximation(Day 1 (End of procedure))
研究者
Salmaan Azam Jawaid, MD
Principal Investigator
Baylor College of Medicine