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

NCT07762820 · tracked via the Priya Life Science Denmark tracker

Sponsor

Ludwig-Maximilians - University of Munich

Phase

Not applicable

Started

2026-09-01

Last updated

2026-08-17

Condition(s) studied

Bladder CancerBladder Cancer TNM Staging Primary Tumor (T) T1

Investigational drug(s) / intervention(s)

CURTIS retrieval 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

Study 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?

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval — 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.

Trial sites (9)

Facility	City	Region
Department of Urology, Aarhus University Hospital, Aarhus	Aarhus	Denmark
Zealand University Hospital, Roskilde	Roskilde	Denmark
Urologie, Universitätsklinikum Augsburg	Augsburg	Bavaria
Universtitätsklinikum Erlangen	Erlangen	Bavaria
Urologie, Barmherzige Brüder Krankenhaus München	Munich	Bavaria
Urologische Klinik und Poliklinik, LMU Klinikum	Munich	Bavaria
Urologische Klinik, Klinikum Rechts der Isar	Munich	Bavaria
Klinik für Urologie, Klinikum Nürnberg, Campus Nord	Nuremberg	Bavaria
Department of Surgery, Queen Ingrid's Hospital	Nuuk	Greenland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07762820 on ClinicalTrials.gov ↗ ← All trials in Denmark