An International Randomized Study to Compare SPIES Versus WLI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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A

SPIES+WLI assisted TURB

Group Type ACTIVE_COMPARATOR

SPIES+WLI assisted TURB

Intervention Type DEVICE

B

WLI assisted TURB

Group Type ACTIVE_COMPARATOR

WLI assisted TURB

Intervention Type DEVICE

Interventions

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SPIES+WLI assisted TURB

Intervention Type DEVICE

WLI assisted TURB

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No