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

13 agosto 2026 aggiornato da: Yannic Volz, Ludwig-Maximilians - University of Munich

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

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?

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Here is the Detailed Description for ClinicalTrials.gov:

Study Design The RETRIEVE-BT Trial is a prospective, multicenter, single-arm, non-randomized feasibility study conducted at multiple urological centers. No control group or randomization is applied, as the study is designed to characterize the technical performance of the CURTIS device under real-world clinical conditions rather than to test a comparative efficacy hypothesis.

The CURTIS Device CURTIS (Urotech GmbH, Achenmühle, Germany) is a CE-marked medical device specifically developed for transurethral retrieval of intact bladder tumor specimens following en bloc resection. The device consists of a hydrophilic-coated retrieval bag that can be opened and closed via a handpiece, enabling controlled capture and safe transurethral extraction of the resected specimen. It is used within its approved intended purpose as defined by EU MDR 2017/745.

Surgical Procedure All procedures are performed under general or spinal anesthesia. En bloc transurethral resection is carried out using a standard resectoscope with an appropriate electrode (e.g., bipolar hook, J-electrode, or needle electrode). A circumferential incision is made in healthy urothelium approximately 3-5 mm lateral to the visible tumor margin, followed by en bloc dissection at the submucosal or muscularis propria level. Once the specimen is fully detached from the bladder wall, CURTIS-assisted retrieval is attempted according to the manufacturer's instructions for use. If retrieval with CURTIS is unsuccessful, conversion to an alternative extraction method is performed at the surgeon's discretion and documented.

Data Collection and Follow-up Data are collected prospectively via an electronic Case Report Form (eCRF). Intraoperative variables recorded include retrieval success or failure, reason for failure if applicable, total procedure time, and dedicated retrieval time. Resected specimens are processed by the local pathology department according to institutional standards; pathological variables include specimen dimensions, muscularis propria presence, pathological T-stage, histological grade (WHO 2022), and resection margin status. Postoperative complications are documented according to the Clavien-Dindo classification until hospital discharge. No additional study-specific outpatient follow-up visits are required.

Statistical Approach This is a pilot feasibility study; the statistical approach is primarily descriptive. The primary endpoint will be reported as an observed proportion with exact 95% Clopper-Pearson confidence interval. A predefined technical feasibility rate of ≥80% is the threshold indicating clinical utility. Secondary endpoints will be analyzed descriptively. A threshold analysis will be applied to identify the maximum tumor size associated with successful intact retrieval.

Tipo di studio

Interventistico

Iscrizione (Stimato)

75

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Danimarca
      • Aarhus, Danimarca, 8200
        • Department of Urology, Aarhus University Hospital, Aarhus
        • Contatto:
      • Roskilde, Danimarca, 4000
  • Germania
    • Bavaria
      • Augsburg, Bavaria, Germania, 86156
      • Erlangen, Bavaria, Germania, 91504
      • Munich, Bavaria, Germania, 80639
      • Munich, Bavaria, Germania, 81377
      • Munich, Bavaria, Germania, 81675
        • Urologische Klinik, Klinikum Rechts der Isar
        • Contatto:
        • Sub-investigatore:
          • Fabian Horné, M.D.
      • Nuremberg, Bavaria, Germania, 90419
  • Groenlandia
      • Nuuk, Groenlandia, 3900
        • Department of Surgery, Queen Ingrid's Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: En-Bloc Retriever Arm
En-bloc resection and retrieval of the tumor with CURTIS device
Dispositivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
Lasso di tempo: 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.
Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum Retrievable Tumor Size
Lasso di tempo: Intraoperatively (measured at time of specimen retrieval)
Largest tumor diameter (in mm) at which successful intact retrieval using CURTIS was achieved, used to define a clinically meaningful upper size limit for CURTIS-assisted EBR-T.
Intraoperatively (measured at time of specimen retrieval)
Proportion of Specimens Containing Muscularis Propria (Detrusor Muscle)
Lasso di tempo: Perioperative/Periprocedural
Proportion of retrieved specimens containing detrusor muscle on pathological examination.
Perioperative/Periprocedural
Proportion of Specimens Permitting Complete Pathological T-Stage Assessment
Lasso di tempo: Perioperative/Periprocedural
Proportion of retrieved specimens allowing complete pathological T-stage assessment (pTa/pT1/pT2+).
Perioperative/Periprocedural
Proportion of Specimens Permitting Histological Grading
Lasso di tempo: Perioperative/Periprocedural
Proportion of retrieved specimens permitting grading according to WHO 2022 classification.
Perioperative/Periprocedural
Proportion of Specimens Permitting Resection Margin Assessment
Lasso di tempo: Perioperative/Periprocedural
Proportion of retrieved specimens permitting assessment of horizontal and vertical resection margin status.
Perioperative/Periprocedural
Total Procedure Time
Lasso di tempo: Intraoperatively (during the index surgical procedure)
Time from cystoscope insertion to complete specimen extraction and withdrawal of all instruments.
Intraoperatively (during the index surgical procedure)
Retrieval Time
Lasso di tempo: Intraoperatively (during the index surgical procedure)
Time from completion of en-bloc resection (detachment of tumor from bladder wall) to complete specimen extraction through the urethra.
Intraoperatively (during the index surgical procedure)
Perioperative Complication Rate (Clavien-Dindo Classification)
Lasso di tempo: From start of procedure until hospital discharge, up to 30 days postoperatively
All intraoperative and postoperative complications occurring from the start of the procedure until hospital discharge, up to 30 postoperative days, classified according to the Clavien-Dindo classification system.
From start of procedure until hospital discharge, up to 30 days postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ludwig-Maximilians - University of Munich

Investigatori

  • Investigatore principale: Yannic T Volz, M.D., Urologische Klinik und Poliklinik, LMU Klinikum München

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

7 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2026

Primo Inserito (Effettivo)

13 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26-0559

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Not able due to ethical and legal obligations

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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