Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer TNM Staging Primary Tumor (T) T1 | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CURTIS retrieval device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- En-Bloc Retriever Arm
- description
- En-bloc resection and retrieval of the tumor with CURTIS device
- interventionNames
- Device: CURTIS retrieval device
Primary outcomes (1)
- measure
- Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
- timeFrame
- Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure)
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available