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NOT YET RECRUITING
NCT07762820
NA

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

Sponsor: Ludwig-Maximilians - University of Munich

View on ClinicalTrials.gov

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?

Official title: REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors - A Prospective Multicenter Feasibility Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-09-01

Completion Date

2027-03-31

Last Updated

2026-08-17

Healthy Volunteers

No

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

Locations (9)

Department of Urology, Aarhus University Hospital, Aarhus

Aarhus, Denmark

Zealand University Hospital, Roskilde

Roskilde, Denmark

Urologie, Universitätsklinikum Augsburg

Augsburg, Bavaria, Germany

Universtitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Urologie, Barmherzige Brüder Krankenhaus München

Munich, Bavaria, Germany

Urologische Klinik und Poliklinik, LMU Klinikum

Munich, Bavaria, Germany

Urologische Klinik, Klinikum Rechts der Isar

Munich, Bavaria, Germany

Klinik für Urologie, Klinikum Nürnberg, Campus Nord

Nuremberg, Bavaria, Germany

Department of Surgery, Queen Ingrid's Hospital

Nuuk, Greenland