A prospective study to evaluate the safety and effectiveness of steerable Ureteroscopic Renal Evacuation (SURE) using CVAC® Set.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint is the stone clearance, defined as percent reduction in stone volume. At post-op day (POD) 1 on NCCT by independent reviewer.
研究概览
简要总结
The CVAC® Set is comprised of the single use CVAC® Aspiration System and the reusable CVAC® Image Processor. The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration and is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney, and to irrigate and apply suction to remove stone and dust fragments in the renal pelvis and calyces during the endoscopic urological kidney stone removal procedure. The CVAC Image Processor is a video processor that is used for clinical image processing. The CVAC Aspiration System is compatible with currently marketed accessories for stone removal, including single-use laser fibers and stone baskets, which are inserted and used in the working channel. The CVAC Image Processor generates a video signal compatible with standard external monitors. The CVAC Set is designed to perform standard ureteroscopy and to remove stone fragments and stone dust using the same device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â‰¥ 18 years of age;
- •Candidate for ureteroscopy with laser lithotripsy;
- •Total renal stone burden of 7 mm.
- •30 mm as measured by the sum of the longest dimension from the axial, coronal or sagittal view (whichever is longest) of each stone on CT within 90 days before the index procedure;
- •Be willing and able to return for and respond to all study-related follow up procedures; and,
- •Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).
排除标准
- •Significant morbidities that in the opinion of the Investigator, could represent an increased perioperative risk for the subject;
- •Challenging renal anatomy that does not allow for initiation of SURE;
- •Ipsilateral partial nephrectomy within 6 months prior to index procedure;
- •History of ipsilateral ureteral reimplantation or ureteral reconstruction;
- •History of urinary diversion;
- •Ureteral ipsilateral stricture, untreated;
- •Ureteral stricture, untreated (not to include “tight†ureter);
- •Ipsilateral impacted ureteral stone (not to include proximal ureter or ureteropelvic junction “UPJ†stones);
- •Medullary sponge kidney;
- •Renal insufficiency requiring dialysis at the time of screening;
- •Bleeding diathesis (anticoagulants that cannot be discontinued); and 13.Any subjects with intraoperative complications, i.e., ureteral trauma, prior to introduction of CVAC®.
结局指标
主要结局
The primary efficacy endpoint is the stone clearance, defined as percent reduction in stone volume. At post-op day (POD) 1 on NCCT by independent reviewer.
时间窗: baseline, 1 day & 4 weeks
次要结局
- The secondary endpoints are listed below.(1. Stone clearance at post-op day (POD) 30)
研究者
Dr Mahesh Desai
Muljibhai Patel Society for Research in Nephro-Urology