Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial Carcinoma
2026年7月9日 更新者：University of Michigan Rogel Cancer Center
A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope
This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma.
Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma.
Ureteroscopy is traditionally performed in an operating room under general anesthesia.
In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind.
Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis.
Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
10
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。
学习联系方式
- 姓名：Michael Uy, MD
- 电话号码：734-936-7030
- 邮箱：Uymichae@med.umich.edu
学习地点
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- 招聘中
- University of Michigan Rogel Cancer Center
-
首席研究员：
- Khurshid Ghani, MD
-
接触：
- Michael Uy, MD
- 电话号码：734-936-7030
- 邮箱：Uymichae@med.umich.edu
-
-
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:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex
- History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment
- Ability and willingness to complete and adhere to survey questions and responses throughout study duration
Exclusion Criteria:
- Known ureteral strictures
- Active urinary tract infection
- Need for general anesthesia due to patient or procedural factors
- History of inability to tolerate ureteroscopy under local anesthetic
- Anticipated need for laser ablation during the surveillance procedure
- Pregnancy
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：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Diagnostic (in office ureteroscopy)
Patients receive lidocaine jelly intraurethrally for local anesthesia.
Patients then undergo ureteroscopy using the 6.3 Fr single use digital ureteroscope.
Per standard of care practice, patients receive pain medication PO on an as needed basis prior to and immediately after the procedure.
|
辅助研究
辅助研究
Given PO
其他名称：
Given intraurethrally
Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope
Undergo ureteroscopy
|
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 |
|---|---|---|
|
Success rate
大体时间：On day of procedure
|
Defined as the ability to successfully perform and complete upper and lower tract surveillance with the 6.3 French ureteroscope in an office setting.
A study-wide successful outcome will be defined as a success rate of 70%.
The success rate will be reported as the count and proportion of participants with a successful outcome out of the number of enrolled participants.
The corresponding 95% binomial Clopper-Pearson confidence interval will be reported.
|
On day of procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain
大体时间：From baseline up to 7-10 days post procedure
|
Assessed by intra- and peri-procedure patient reported outcomes with the visual analogue scale pain score, as well as the Patient-Reported Outcomes Measurement Information System Pain Interference and Intensity score.
Will be summarized and displayed graphically with means, standard deviations and/or quartiles.
|
From baseline up to 7-10 days post procedure
|
|
Satisfaction
大体时间：At 7-10 days post procedure
|
Assessed by the International Consultation on Incontinence-Satisfaction. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.
|
At 7-10 days post procedure
|
|
Unplanned healthcare use
大体时间：From baseline up to 30 days post procedure
|
Will measure unplanned healthcare utilization including electronic messages, phone calls, lab and imaging tests, emergency department visits, hospitalizations, and secondary interventions.
These will be reported as counts of events and counts of participants with corresponding proportions of enrolled participants.
|
From baseline up to 30 days post procedure
|
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：Khurshid Ghani, MD、University of Michigan Rogel Cancer Center
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 (估计的)
2026年8月1日
初级完成 (估计的)
2027年8月1日
研究完成 (估计的)
2027年8月1日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7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
- UMCC 2025.155
- NCI-2026-03864 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- HUM00284243
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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
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.