Intrarenal Pressure in Suctioning vs. Non-suctioning Sheaths
2026年5月26日 更新者:Mantu Gupta、Icahn School of Medicine at Mount Sinai
Comparing the Intrarenal Pressure Between Suctioning and Non-Suctioning Access Sheaths Using the LithoVue Elite Ureteroscope System
Interest in monitoring intrarenal pressure (IRP) during flexible ureteroscopy (fURS) has grown, especially due to its potential association with improved postoperative efficiency and safety.
A prominent technique for managing IRP during fURS is the use of ureteral access sheaths (UAS), which are known to reduce IRP.
Suction-equipped access sheaths provide additional benefits by continuously evacuating dust and stone fragments during the procedure, potentially enhancing stone-free rates.
However, IRP during suctioning procedures has yet to be thoroughly investigated.
The aim of this study is to compare the IRP during fURS using UAS with and without suctioning technique.
研究概览
详细说明
Interest in monitoring intrarenal pressure (IRP) during flexible ureteroscopy (fURS) has grown, especially due to its potential association with improved postoperative efficiency and safety.
With advances in technology, precise tools like the LithoVue™ Elite now enables continuous IRP measurement, facilitating accurate data collection throughout the procedure.
A prominent technique for managing IRP during fURS is the use of ureteral access sheaths (UAS), which are known to reduce IRP.
Suction-equipped access sheaths provide additional benefits by continuously evacuating dust and stone fragments during the procedure, potentially enhancing stone-free rates (SFR).
However, IRP during suctioning procedures has yet to be thoroughly investigated.
This study is a randomized controlled trial comparing continuous intrarenal pressure (IRP) measurements during flexible ureteroscopy (fURS) using a suctioning ureteral access sheath (UAS) versus a non-suctioning UAS.
The study will be conducted over an 18-month period and will include all patients over 18 years of age who are scheduled to undergo fURS for a stone burden greater than 1 cm and/or multiple stones.
Patients who are pregnant, have an untreated urinary tract infection (UTI), urinary tract anomalies such as urinary diversion, ureteral reconstruction, or horseshoe kidney, or who have a single stone smaller than 1 cm will be excluded from participation.
All procedures will take place at Mount Sinai West, with patients enrolled from the practices of two endourology-trained specialists, Dr. William Atallah and Dr. Mantu Gupta.
Participants will be randomized to either the suctioning-UAS arm using the ClearPETRA Flexible and Navigable Suction UAS or the non-suctioning-UAS arm using the BSC Navigator device.
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
New York、New York、美国、10019
- Mount Sinai West
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
INCLUSION CRITERIA
- Adults aged 18 years and older.
- Diagnosed with kidney stones and scheduled for fURS.
- Stone burden > 1 cm and/or multiple stones will be eligible.
- Able and willing to provide informed consent.
EXCLUSION CRITERIA
- Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at our institution)
- Untreated UTI
- Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
- Single stone < 1 cm
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Suctioning-UAS
Placement of the ClearPETRA Flexible and Navigable Suction UAS during flexible ureteroscopy with continuous suction applied during stone treatment.
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Participants undergoing flexible ureteroscopy (fURS) will receive a suctioning ureteral access sheath using the ClearPETRA Flexible and Navigable Suction UAS.
Continuous intrarenal pressure (IRP) measurements will be recorded throughout the procedure using the LithoVue Elite ureteroscope system.
|
|
有源比较器:Non-suctioning-UAS
Placement of the BSC Navigator during flexible ureteroscopy without suction during stone treatment.
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Participants undergoing flexible ureteroscopy (fURS) will receive a standard non-suctioning ureteral access sheath using the BSC Navigator device.
Continuous intrarenal pressure (IRP) measurements will be recorded throughout the procedure using the LithoVue Elite ureteroscope system.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intrarenal Pressure (IRP) During Flexible Ureteroscopy
大体时间:Intraoperative (during procedure)
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Continuous measurement of intrarenal pressure using the LithoVue Elite ureteroscope system.
|
Intraoperative (during procedure)
|
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Time spent above Intrarenal Pressure (IRP) threshold during Flexible Ureteroscopy
大体时间:Intraoperative (during procedure)
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Time spent above Intrarenal Pressure (IRP) thresholds of 20, 40, 60, 80, and 100 mmHg using the LithoVue Elite ureteroscope system.
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Intraoperative (during procedure)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stone-Free Rate (SFR) on Postoperative CT Imaging
大体时间:4-8 weeks postoperatively
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Rate of stone-free status assessed by non-contrast CT scan using a 4-grade scale (Grade A: completely stone-free; Grade B: residual fragments <2 mm; Grade C: residual fragments 2-4 mm; Grade D: residual fragments >4 mm).
|
4-8 weeks postoperatively
|
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Postoperative Pain Score (VAS)
大体时间:In the Post-Anesthesia Care Unit (PACU), prior to discharge on the day of surgery (on average 1.5 hours post operatively)
|
Visual Analog Scale (VAS) pain score.
Scale ranges from 0 (no pain) to 10 (worst pain imaginable); higher scores indicate greater pain intensity.
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In the Post-Anesthesia Care Unit (PACU), prior to discharge on the day of surgery (on average 1.5 hours post operatively)
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Number of Postoperative Complications
大体时间:30 days postoperatively
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Number of any postoperative complications occurring within 30 days of the procedure (as defined by the study protocol and standard Clavien-Dindo classification or similar).
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30 days postoperatively
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Mantu Gupta, MD、Icahn School of Medicine at Mount Sinai
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年4月3日
初级完成 (实际的)
2025年10月10日
研究完成 (实际的)
2025年12月5日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年5月26日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月26日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY-25-00111
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
To to protect participant privacy
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.