REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors (RETRIEVE-BT)
REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors - A Prospective Multicenter Feasibility Study
Bladder cancer is the most common malignancy of the urinary tract, and approximately 75% of cases are non-muscle invasive (NMIBC) at diagnosis. The standard treatment is transurethral resection of the bladder tumor (TURBT). En bloc resection (EBR-T), in which the tumor is removed in one intact piece rather than fragmented, offers superior pathological specimen quality and may reduce the need for repeat resections. However, extracting the intact specimen from the bladder through the urethra remains a critical technical challenge, particularly for larger tumors.
CURTIS (Urotech GmbH) is a CE-marked retrieval device consisting of a hydrophilic-coated bag that can be opened and closed via a handpiece, enabling controlled capture and safe transurethral extraction of the resected tumor specimen.
This study aims to evaluate the technical feasibility of CURTIS-assisted intact specimen retrieval following en bloc transurethral resection of primary NMIBC. The central question the study seeks to answer is: in what proportion of cases can CURTIS successfully retrieve an intact en bloc resected bladder tumor, and what is the maximum tumor size for which intact retrieval remains feasible?
研究概览
详细说明
Here is the Detailed Description for ClinicalTrials.gov:
Study Design The RETRIEVE-BT Trial is a prospective, multicenter, single-arm, non-randomized feasibility study conducted at multiple urological centers. No control group or randomization is applied, as the study is designed to characterize the technical performance of the CURTIS device under real-world clinical conditions rather than to test a comparative efficacy hypothesis.
The CURTIS Device CURTIS (Urotech GmbH, Achenmühle, Germany) is a CE-marked medical device specifically developed for transurethral retrieval of intact bladder tumor specimens following en bloc resection. The device consists of a hydrophilic-coated retrieval bag that can be opened and closed via a handpiece, enabling controlled capture and safe transurethral extraction of the resected specimen. It is used within its approved intended purpose as defined by EU MDR 2017/745.
Surgical Procedure All procedures are performed under general or spinal anesthesia. En bloc transurethral resection is carried out using a standard resectoscope with an appropriate electrode (e.g., bipolar hook, J-electrode, or needle electrode). A circumferential incision is made in healthy urothelium approximately 3-5 mm lateral to the visible tumor margin, followed by en bloc dissection at the submucosal or muscularis propria level. Once the specimen is fully detached from the bladder wall, CURTIS-assisted retrieval is attempted according to the manufacturer's instructions for use. If retrieval with CURTIS is unsuccessful, conversion to an alternative extraction method is performed at the surgeon's discretion and documented.
Data Collection and Follow-up Data are collected prospectively via an electronic Case Report Form (eCRF). Intraoperative variables recorded include retrieval success or failure, reason for failure if applicable, total procedure time, and dedicated retrieval time. Resected specimens are processed by the local pathology department according to institutional standards; pathological variables include specimen dimensions, muscularis propria presence, pathological T-stage, histological grade (WHO 2022), and resection margin status. Postoperative complications are documented according to the Clavien-Dindo classification until hospital discharge. No additional study-specific outpatient follow-up visits are required.
Statistical Approach This is a pilot feasibility study; the statistical approach is primarily descriptive. The primary endpoint will be reported as an observed proportion with exact 95% Clopper-Pearson confidence interval. A predefined technical feasibility rate of ≥80% is the threshold indicating clinical utility. Secondary endpoints will be analyzed descriptively. A threshold analysis will be applied to identify the maximum tumor size associated with successful intact retrieval.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yannic T PD Dr. Volz, M.D.
- 电话号码：+4989440071357
- 邮箱：yannic.volz@med.uni-muenchen.de
学习地点
-
-
-
Aarhus、丹麦、8200
- Department of Urology, Aarhus University Hospital, Aarhus
-
接触：
- Pernille S Kingo
- 邮箱：pernking@rm.dk
-
Roskilde、丹麦、4000
- Zealand University Hospital, Roskilde
-
接触：
- Juan L. Vasquez
- 邮箱：julv@regionsjaelland.dk
-
-
-
-
Bavaria
-
Augsburg、Bavaria、德国、86156
- Urologie, Universitätsklinikum Augsburg
-
接触：
- Roman Mayr, M.D., Prof.
- 邮箱：roman.mayr@uk-augsburg.de
-
Erlangen、Bavaria、德国、91504
- Universtitätsklinikum Erlangen
-
接触：
- Christian Fiebig, M.D.
- 邮箱：Christian.Fiebig@uk-erlangen.de
-
Munich、Bavaria、德国、80639
- Urologie, Barmherzige Brüder Krankenhaus München
-
接触：
- Alexander Prof. Karl, M.D., Prof.
- 邮箱：Alexander.Karl@barmherzige-muenchen.de
-
副研究员：
- Theresa Kahl, M.D.
-
Munich、Bavaria、德国、81377
- Urologische Klinik und Poliklinik, LMU Klinikum
-
接触：
- Yannic Volz, M.D.
- 邮箱：yannic.volz@med.uni-muenchen.de
-
Munich、Bavaria、德国、81675
- Urologische Klinik, Klinikum Rechts der Isar
-
接触：
- Michael Straub, M.D.
- 邮箱：michael.straub@tum.de
-
副研究员：
- Fabian Horné, M.D.
-
Nuremberg、Bavaria、德国、90419
- Klinik für Urologie, Klinikum Nürnberg, Campus Nord
-
接触：
- Gloria Zeitler, M.D.
- 邮箱：Gloria.Zeitler@klinikum-nuernberg.de
-
-
-
-
-
Nuuk、格陵兰、3900
- Department of Surgery, Queen Ingrid's Hospital
-
接触：
- Jørgen B Jensen
- 邮箱：jb@skejby.net
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years at the time of enrollment
- Suspected primary non-muscle invasive bladder cancer (NMIBC; stage pTa or pT1) based on cystoscopic assessment, with no radiological or clinical evidence of muscle-invasive disease
- Solitary or multiple bladder tumors with an estimated largest diameter of ≤50 mm based on flexible or rigid cystoscopic assessment (or cross-sectional imaging if available)
- Clinical indication for elective transurethral resection of the bladder tumor, planned to be performed as en-bloc resection
- Written informed consent obtained prior to any study-related procedure
- Ability to understand the study procedures and willingness to comply with study requirements
Exclusion Criteria:
- Known or clinically suspected muscle-invasive bladder cancer (MIBC; cT2 or higher) based on cystoscopy or imaging
- Recurrent bladder tumor (prior history of bladder tumor resection within the past 24 months)
- Active untreated urinary tract infection at the time of surgery (requiring postponement and re-evaluation)
- Uncorrectable coagulopathy or anticoagulation that cannot be safely paused perioperatively
- Severe urethral stricture precluding standard resectoscope passage
- Inability to provide written informed consent (e.g., due to cognitive impairment or language barrier without translation support)
学习计划
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：En-Bloc Retriever Arm
En-bloc resection and retrieval of the tumor with CURTIS device
|
After successful en-bloc resection, the tumor is retrieved using the novel retrieval device, where the tumor is catched with a bag and removed through the urethra
|
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 |
|---|---|---|
|
Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
大体时间：Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure)
|
Proportion of enrolled patients in whom the CURTIS device enables complete, intact retrieval of the en-bloc resected bladder tumor specimen without fragmentation within the bladder or urethra.
A case is classified as a technical success if the entire resected specimen is extracted through the urethra in one piece using the CURTIS device.
Cases requiring conversion to an alternative retrieval method (e.g., piecemeal extraction, Ellik evacuator, endoscopic bag) are classified as technical failures.
|
Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Retrievable Tumor Size
大体时间：Intraoperatively (measured at time of specimen retrieval)
|
Largest tumor diameter (in mm) at which successful intact retrieval using CURTIS was achieved, used to define a clinically meaningful upper size limit for CURTIS-assisted EBR-T.
|
Intraoperatively (measured at time of specimen retrieval)
|
|
Proportion of Specimens Containing Muscularis Propria (Detrusor Muscle)
大体时间：Perioperative/Periprocedural
|
Proportion of retrieved specimens containing detrusor muscle on pathological examination.
|
Perioperative/Periprocedural
|
|
Proportion of Specimens Permitting Complete Pathological T-Stage Assessment
大体时间：Perioperative/Periprocedural
|
Proportion of retrieved specimens allowing complete pathological T-stage assessment (pTa/pT1/pT2+).
|
Perioperative/Periprocedural
|
|
Proportion of Specimens Permitting Histological Grading
大体时间：Perioperative/Periprocedural
|
Proportion of retrieved specimens permitting grading according to WHO 2022 classification.
|
Perioperative/Periprocedural
|
|
Proportion of Specimens Permitting Resection Margin Assessment
大体时间：Perioperative/Periprocedural
|
Proportion of retrieved specimens permitting assessment of horizontal and vertical resection margin status.
|
Perioperative/Periprocedural
|
|
Total Procedure Time
大体时间：Intraoperatively (during the index surgical procedure)
|
Time from cystoscope insertion to complete specimen extraction and withdrawal of all instruments.
|
Intraoperatively (during the index surgical procedure)
|
|
Retrieval Time
大体时间：Intraoperatively (during the index surgical procedure)
|
Time from completion of en-bloc resection (detachment of tumor from bladder wall) to complete specimen extraction through the urethra.
|
Intraoperatively (during the index surgical procedure)
|
|
Perioperative Complication Rate (Clavien-Dindo Classification)
大体时间：From start of procedure until hospital discharge, up to 30 days postoperatively
|
All intraoperative and postoperative complications occurring from the start of the procedure until hospital discharge, up to 30 postoperative days, classified according to the Clavien-Dindo classification system.
|
From start of procedure until hospital discharge, up to 30 days postoperatively
|
合作者和调查者
调查人员
- 首席研究员：Yannic T Volz, M.D.、Urologische Klinik und Poliklinik, LMU Klinikum München
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 26-0559
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.