REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors - A Prospective Multicenter Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 9
- 主要终点
- Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
En-Bloc Retriever Arm
En-bloc resection and retrieval of the tumor with CURTIS device
干预措施: CURTIS retrieval device (Device)
结局指标
主要结局
Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
时间窗: 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.
次要结局
- Maximum Retrievable Tumor Size(Intraoperatively (measured at time of specimen retrieval))
- Proportion of Specimens Containing Muscularis Propria (Detrusor Muscle)(Perioperative/Periprocedural)
- Proportion of Specimens Permitting Complete Pathological T-Stage Assessment(Perioperative/Periprocedural)
- Proportion of Specimens Permitting Histological Grading(Perioperative/Periprocedural)
- Proportion of Specimens Permitting Resection Margin Assessment(Perioperative/Periprocedural)
- Total Procedure Time(Intraoperatively (during the index surgical procedure))
- Retrieval Time(Intraoperatively (during the index surgical procedure))
- Perioperative Complication Rate (Clavien-Dindo Classification)(From start of procedure until hospital discharge, up to 30 days postoperatively)
研究者
Yannic Volz
Priv.-Doz. Dr. med. Yannic Volz
Ludwig-Maximilians - University of Munich