REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors

Sponsor
Ludwig-Maximilians - University of Munich
Study ID
NCT07762820
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CURTIS retrieval device — 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

Study Details

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?

Key Dates

First listed
Aug 13, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: En-Bloc Retriever Arm
    En-bloc resection and retrieval of the tumor with CURTIS device

Primary Outcome Measure

Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval [ Time Frame: Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure) ]

Central Contacts

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