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

NCT07762820

Not Yet RecruitingNA

Sponsor: Ludwig-Maximilians - University of Munich

Conditions: Bladder Cancer, Bladder Cancer TNM Staging Primary Tumor (T) T1

Interventions: CURTIS retrieval device

Countries: Denmark, Germany, Greenland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (9)
  • Aarhus, Denmark
  • Roskilde, Denmark
  • Augsburg, Bavaria, Germany
  • Erlangen, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Nuremberg, Bavaria, Germany
  • Nuuk, Greenland