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An International Randomized Study to Compare SPIES Versus WLI

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPIES+WLI assisted TURB
WLI assisted TURB
Sponsored by
Clinical Research Office of the Endourological Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    SPIES+WLI assisted TURB

    WLI assisted TURB

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 26, 2014
    Last Updated
    July 27, 2021
    Sponsor
    Clinical Research Office of the Endourological Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02252549
    Brief Title
    An International Randomized Study to Compare SPIES Versus WLI
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    April 2020 (Actual)
    Study Completion Date
    July 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clinical Research Office of the Endourological Society

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    700 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    SPIES+WLI assisted TURB
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    WLI assisted TURB
    Intervention Type
    Device
    Intervention Name(s)
    SPIES+WLI assisted TURB
    Intervention Type
    Device
    Intervention Name(s)
    WLI assisted TURB
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean de la Rosette
    Organizational Affiliation
    Clinical Research Office of the Endourological Society
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34741631
    Citation
    de la Rosette J, Martov A, Hurle R, Favre G, Mamoulakis C, Castanheira de Oliveira M, Stenzl A, Linares-Espinos E, Trelles Guzman CR, Gravas S, Knoll T, Boz MY, Herrmann T, Laguna P. Conventional white light imaging-assisted transurethral resection of bladder tumour (TURBT) versus IMAGE1S-assisted TURBT in non-muscle-invasive bladder cancer patients: trial protocol and 18 months results. World J Urol. 2022 Mar;40(3):727-738. doi: 10.1007/s00345-021-03866-4. Epub 2021 Nov 6.
    Results Reference
    derived

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    An International Randomized Study to Compare SPIES Versus WLI

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