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

NCT07762820 | Not Yet Recruiting

• 1 other identifier: 26-0559
• Study Type: interventional
• Target: 75
• Locations: 3 countries
• Sites: 9

Brief 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?

Conditions

Bladder Cancer; Bladder Cancer TNM Staging Primary Tumor (T) T1

Keywords

bladder cancer; urothelial cell cancer; en-bloc; retrieval; transurethral resection of bladder tumor; TUR-BT

Outcome Measures

Primary Outcomes (1)

• Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval

  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)

Secondary Outcomes (8)

• Maximum Retrievable Tumor Size

  Intraoperatively (measured at time of specimen retrieval)

• Proportion of Specimens Containing Muscularis Propria (Detrusor Muscle)

  Perioperative/Periprocedural

• Proportion of Specimens Permitting Complete Pathological T-Stage Assessment

  Perioperative/Periprocedural

• Proportion of Specimens Permitting Histological Grading

  Perioperative/Periprocedural

• Proportion of Specimens Permitting Resection Margin Assessment

  Perioperative/Periprocedural

Study Arms (1)

En-Bloc Retriever Arm

EXPERIMENTAL

En-bloc resection and retrieval of the tumor with CURTIS device

Device: CURTIS retrieval device

Interventions

CURTIS retrieval device 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

En-Bloc Retriever Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (9)

Department of Urology, Aarhus University Hospital, Aarhus

Aarhus, 8200, Denmark

Location

Zealand University Hospital, Roskilde

Roskilde, 4000, Denmark

Location

Urologie, Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

Location

Universtitätsklinikum Erlangen

Erlangen, Bavaria, 91504, Germany

Location

Urologie, Barmherzige Brüder Krankenhaus München

Munich, Bavaria, 80639, Germany

Location

Urologische Klinik und Poliklinik, LMU Klinikum

Munich, Bavaria, 81377, Germany

Location

Urologische Klinik, Klinikum Rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Klinik für Urologie, Klinikum Nürnberg, Campus Nord

Nuremberg, Bavaria, 90419, Germany

Location

Department of Surgery, Queen Ingrid's Hospital

Nuuk, 3900, Greenland

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Yannic T Volz, M.D.

  Urologische Klinik und Poliklinik, LMU Klinikum München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannic T PD Dr. Volz, M.D.

CONTACT

+4989440071357; yannic.volz@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med. Yannic Volz

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); DE (6); GR (1)