NCT02252549

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

September 26, 2014

Last Update Submit

July 27, 2021

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (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)

    1 year

Secondary Outcomes (2)

  • 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.

    3 years

  • 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.

    3 years

Study Arms (2)

A

ACTIVE COMPARATOR

SPIES+WLI assisted TURB

Device: SPIES+WLI assisted TURB

B

ACTIVE COMPARATOR

WLI assisted TURB

Device: WLI assisted TURB

Interventions

SPIES+WLI assisted TURBDEVICE
A
WLI assisted TURBDEVICE
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34741631DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jean de la Rosette

    Clinical Research Office of the Endourological Society

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

April 1, 2015

Primary Completion

April 1, 2020

Study Completion

July 1, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07