NCT07762820Not yet recruiting
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 - A Prospective Multicenter Feasibility Study
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Diseases
- Bladder cancer
- NCT number
- NCT07762820
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 1 Sept 2026 to the primary completion date, 30 Dec 2026
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recurrent bladder tumor (prior history of bladder tumor resection within the past 24 months)
Other illness
- Known or clinically suspected muscle-invasive bladder cancer (MIBC; cT2 or higher) based on cystoscopy or imaging
- Active untreated urinary tract infection at the time of surgery (requiring postponement and re-evaluation)
- Inability to provide written informed consent (e.g., due to cognitive impairment or language barrier without translation support)
Other
- Uncorrectable coagulopathy or anticoagulation that cannot be safely paused perioperatively
- Severe urethral stricture precluding standard resectoscope passage
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urologie, Universitätsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Universtitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Urologische Klinik und Poliklinik, LMU Klinikum Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Urologische Klinik, Klinikum Rechts der Isar Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Urologie, Barmherzige Brüder Krankenhaus München Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Klinik für Urologie, Klinikum Nürnberg, Campus Nord Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Department of Urology, Aarhus University Hospital, Aarhus Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Zealand University Hospital, Roskilde Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
| Department of Surgery, Queen Ingrid's Hospital Coordinator of this site? Confirm its status | Nuuk | Greenland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.