ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach in Retrograde Intrarenal Surgery. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Stone Free Status between ClearPetra and traditional approach
研究概览
简要总结
Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure.
Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration.
Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.
详细描述
Retrograde intrarenal surgery (RIRS) is now considered gold-standard for treatment of renal stones smaller than 2 cm. This procedure often employs a ureteral access sheath (UAS), as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required. However, the challenge imposed by residual stone fragments and sepsis remains. Additionally, natural elimination of residual stone fragments may induce renal colic, hematuria an even the potential for new stone development. Recently, a new vacuum-assisted ureteral access sheath (VA-UAS) named ClearPetra™ provides concomitant stone fragmentation and aspiration.
The new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath equipped with a continuous flow aspiration mechanism. Previous studies have demonstrated the safety and effectiveness of ClearPetra™ in RIRS Comprehensive comparative investigations between ClearPetra™ and traditional UAS in RIRS are lacking in American population. We aim to compare the outcomes of using VA-UAS (ClearPetra™) or traditional approach (no sheath or non-vacuum-assisted sheath) to treat patients with stone burden between 1.0 - 2.5 cm.
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
- 是
入选标准
- •Males or females over18 years of age
- •Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
- •Total stone burden between 1.0 to 2.5 cm
排除标准
- •Undergoing bilateral stone treatment during the same procedure
- •Patients with known genitourinary anatomical abnormalities
- •Uncorrected coagulopathy
- •Patients with urinary diversions
- •Chronic external urinary catheters
- •Women who are pregnant
- •Immunosuppressed patients
- •Non-elective procedures
研究组 & 干预措施
1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH
In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath.
Participants will undergo RIRS per standard of care.
干预措施: ClearPetra Ureteral access sheath (Device)
2. RIRS WITH TRADITIONAL APPROACH
In Arm 2, participants will undergo RIRS a traditional approach (no sheath or non-vacuum-assisted sheath). The treating investigator will decide whether to use a regular UAS based on their preference and/or availability.
- No ureteral access sheath
- Navigator™ Ureteral Access Sheath 11/13 Fr (Boston Scientific®)
- Navigator™ Ureteral Access Sheath 12/14 Fr (Boston Scientific®)
结局指标
主要结局
Stone Free Status between ClearPetra and traditional approach
时间窗: 90 days
Stone free is defined as no residual stones \>2mm in post operative CT scan
次要结局
- Total operative time between ClearPetra and traditional approach(1 day)
- Urinary tract infection between ClearPetra and traditional approach(30 days of procedure)
研究者
Wilson Molina
Professor of Urology
University of Kansas Medical Center