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Ongoing Projects > SPIES RCT

THE SPIES NON-MUSCLE-INVASIVE BLADDER CANCER STUDY – A MULTICENTER RANDOMIZED CONTROLLED STUDY

A Multicenter International Randomized Controlled Study to compare the outcome using the Storz Professional Image Enhancement System (SPIES) versus White Light Imaging (WLI) during TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).

 

Protocol ID: NL50451.018.14 - SPIES vs WL RCT


Primary study objective:

To compare the recurrence rate of tumor at 12 months following SPIES assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B) in patients with primary or recurrent non-muscle-invasive urothelial bladder cancer (NMIBC Ta/T1/CIS). A subgroup analysis will be carried out for patients presenting with only primary tumors.

 

Secondary study objectives:

1. To assess the recurrence rate of tumor at short and long term follow up (3 months and 3 years) after SPIES or WLI assisted TURB in patients with NMIBC.

2. To assess the peri-operative morbidity (30 days) between SPIES and WLI assisted TURB by comparing the proportion of adverse events and using the Clavien-Dindo score. 




 

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

-       Has signed informed consent

-       Is scheduled for treatment of a primary or recurrent NMIBC

-       Is aged 18 years or older

-       Has or has had no tumors in the upper urinary tract

-       Has had no previous irradiation of the pelvis

A potential subject who meets any of the following criteria will be excluded from participation in this study:

-       Gross haematuria at the time of TURB  (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)

-       Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days

-       Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)

-       Conditions associated with a risk of poor protocol compliance

-       Has had instillation therapy in the six months prior to the screening visit


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Click here to download the patient information

Sybill Storz
Sybill Storz
Sybill Storz
Mr. Helmut Wehrstein
Mr. Eric Dourver

Since the company KARL STORZ was founded in 1945, more than half a century has passed – a period of time during which the enterprise has written a significant chapter of medical and technological history. Karl Storz had a vision which was transformed into reality and has been extended through to his very day thanks to pioneering discoveries and inventions.

Modern high-technology medical systems consist of components from the most diverse fields of engineering : optics, mechanics and electronics must work in perfect harmony if the instruments are to function as desired. As simple as the requirement for a harmonious interplay of the individual components may sound, its realization is in fact a highly complex matter.

No matter how much meticulous care is given to development, the quality of the end product is decided by day-to-day manufacturing routine. The perfect instrument can only be created when all components are ideally matched and coordinated.

Our company attains this high quality by ensuring that each and every component is developed, manufactured and subjected to a constant quality control process at our own company. This concept guarantees a maximum of functionality and quality for each individual endoscopic system. The continuity of this quality-consciousness is ensured by the company´s tenet of training its employees from all sectors at our own company.

KARL STORZ will maintain and extend even further its leading position in technological development. However, genuine progress is rarely spectacular – it is the result of countless individual steps that are subjected to repeated scrutiny. 

In accordance with this philosophy, KARL STORZ decided to support the CROES study. This kind of study, exploring the different ways of treatment and using different technologies, is an ideal field to collect a wide variety of information and to prepare the future.    


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