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An International Randomized Study to Compare SPIES Versus WLI

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ClinicalTrials.gov Identifier: NCT02252549
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society

Brief Summary:
This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as short and long-term follow up.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: SPIES+WLI assisted TURB Device: WLI assisted TURB Not Applicable

Detailed Description:
This study is a multicenter randomized controlled trial in which the recurrence rates of cancer between SPIES assisted and WLI assisted TURB are compared. Randomization is stratified by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and macroscopic findings (papillary or flat, where CIS is scored as flat lesion). Patients randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB, whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB. WLI is chosen as control, since it is considered the gold standard for detecting bladder tumors. Short and long term follow up will be recorded in order to evaluate the health gains for patients over a longer period. Perioperative (30 days) complications will be compared between the two treatment arms to evaluate the safety of SPIES.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: 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).
Study Start Date : April 2015
Actual Primary Completion Date : April 2020
Actual Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: A
SPIES+WLI assisted TURB
Device: SPIES+WLI assisted TURB
Active Comparator: B
WLI assisted TURB
Device: WLI assisted TURB



Primary Outcome Measures :
  1. 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) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]
  2. 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. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252549


Sponsors and Collaborators
Clinical Research Office of the Endourological Society
Investigators
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Study Chair: Jean de la Rosette Clinical Research Office of the Endourological Society
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier: NCT02252549    
Other Study ID Numbers: NL50451.018.14
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases