An International Randomized Study to Compare SPIES Versus... | NCT02252549

Studies
An International Randomized Study to Compare SPIES Versus WLI

NCT02252549

Sponsor

Clinical Research Office of the Endourological Society

Status

Completed

Last Update Posted

Jul 28, 2021Actual

Enrollment

700Actual

Phase

Not Applicable

Conditions

Bladder Cancer

Interventions

SPIES+WLI assisted TURB
WLI assisted TURB

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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).

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2020Actual

Completion Date

Jul 2021Actual

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Sep 26, 2014

First Posted Date

Sep 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2021

Last Update Posted Date

Jul 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	SPIES+WLI assisted TURB	Device: SPIES+WLI assisted TURB
B	Active Comparator	WLI assisted TURB	Device: WLI assisted TURB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPIES+WLI assisted TURB	Device		A
WLI assisted TURB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean de la Rosette	Clinical Research Office of the Endourological Society	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34741631	Derived	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.

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms