REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors
NCT07762820 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-08-13
Summary
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?
Conditions
- Bladder Cancer
- Bladder Cancer TNM Staging Primary Tumor (T) T1
Interventions
- DEVICE
-
CURTIS retrieval 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
Sponsors & Collaborators
-
Ludwig-Maximilians - University of Munich
lead OTHER
Principal Investigators
-
Yannic T Volz, M.D. · Urologische Klinik und Poliklinik, LMU Klinikum München
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2026-12-30
- Completion
- 2027-03-31
Countries
- Denmark
- Germany
- Greenland
Study Locations
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