REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors (RETRIEVE-BT)
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?
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Yannic T PD Dr. Volz, M.D.
- Telefonszám: +4989440071357
- E-mail: yannic.volz@med.uni-muenchen.de
Tanulmányi helyek
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Aarhus, Dánia, 8200
- Department of Urology, Aarhus University Hospital, Aarhus
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Kapcsolatba lépni:
- Pernille S Kingo
- E-mail: pernking@rm.dk
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Roskilde, Dánia, 4000
- Zealand University Hospital, Roskilde
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Kapcsolatba lépni:
- Juan L. Vasquez
- E-mail: julv@regionsjaelland.dk
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Nuuk, Grönland, 3900
- Department of Surgery, Queen Ingrid's Hospital
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Kapcsolatba lépni:
- Jørgen B Jensen
- E-mail: jb@skejby.net
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Bavaria
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Augsburg, Bavaria, Németország, 86156
- Urologie, Universitätsklinikum Augsburg
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Kapcsolatba lépni:
- Roman Mayr, M.D., Prof.
- E-mail: roman.mayr@uk-augsburg.de
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Erlangen, Bavaria, Németország, 91504
- Universtitätsklinikum Erlangen
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Kapcsolatba lépni:
- Christian Fiebig, M.D.
- E-mail: Christian.Fiebig@uk-erlangen.de
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Munich, Bavaria, Németország, 80639
- Urologie, Barmherzige Brüder Krankenhaus München
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Kapcsolatba lépni:
- Alexander Prof. Karl, M.D., Prof.
- E-mail: Alexander.Karl@barmherzige-muenchen.de
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Alkutató:
- Theresa Kahl, M.D.
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Munich, Bavaria, Németország, 81377
- Urologische Klinik und Poliklinik, LMU Klinikum
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Kapcsolatba lépni:
- Yannic Volz, M.D.
- E-mail: yannic.volz@med.uni-muenchen.de
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Munich, Bavaria, Németország, 81675
- Urologische Klinik, Klinikum Rechts der Isar
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Kapcsolatba lépni:
- Michael Straub, M.D.
- E-mail: michael.straub@tum.de
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Alkutató:
- Fabian Horné, M.D.
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Nuremberg, Bavaria, Németország, 90419
- Klinik für Urologie, Klinikum Nürnberg, Campus Nord
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Kapcsolatba lépni:
- Gloria Zeitler, M.D.
- E-mail: Gloria.Zeitler@klinikum-nuernberg.de
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Diagnosztikai
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: En-Bloc Retriever Arm
En-bloc resection and retrieval of the tumor with CURTIS device
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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
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Technical Feasibility Rate of CURTIS-Assisted Intact Specimen Retrieval
Időkeret: Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure)
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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.
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Intraoperatively (single assessment at the time of specimen retrieval during the index surgical procedure)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Maximum Retrievable Tumor Size
Időkeret: Intraoperatively (measured at time of specimen retrieval)
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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.
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Intraoperatively (measured at time of specimen retrieval)
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Proportion of Specimens Containing Muscularis Propria (Detrusor Muscle)
Időkeret: Perioperative/Periprocedural
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Proportion of retrieved specimens containing detrusor muscle on pathological examination.
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Perioperative/Periprocedural
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Proportion of Specimens Permitting Complete Pathological T-Stage Assessment
Időkeret: Perioperative/Periprocedural
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Proportion of retrieved specimens allowing complete pathological T-stage assessment (pTa/pT1/pT2+).
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Perioperative/Periprocedural
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Proportion of Specimens Permitting Histological Grading
Időkeret: Perioperative/Periprocedural
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Proportion of retrieved specimens permitting grading according to WHO 2022 classification.
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Perioperative/Periprocedural
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Proportion of Specimens Permitting Resection Margin Assessment
Időkeret: Perioperative/Periprocedural
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Proportion of retrieved specimens permitting assessment of horizontal and vertical resection margin status.
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Perioperative/Periprocedural
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Total Procedure Time
Időkeret: Intraoperatively (during the index surgical procedure)
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Time from cystoscope insertion to complete specimen extraction and withdrawal of all instruments.
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Intraoperatively (during the index surgical procedure)
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Retrieval Time
Időkeret: Intraoperatively (during the index surgical procedure)
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Time from completion of en-bloc resection (detachment of tumor from bladder wall) to complete specimen extraction through the urethra.
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Intraoperatively (during the index surgical procedure)
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Perioperative Complication Rate (Clavien-Dindo Classification)
Időkeret: From start of procedure until hospital discharge, up to 30 days postoperatively
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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.
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From start of procedure until hospital discharge, up to 30 days postoperatively
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Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Yannic T Volz, M.D., Urologische Klinik und Poliklinik, LMU Klinikum München
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 26-0559
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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