NCT02800473

Brief Summary

This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall. All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project. The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

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

June 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

July 4, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2017

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

June 6, 2016

Last Update Submit

March 4, 2021

Conditions

Bladder Cancer

Keywords

Bladder cancerHexvixBimodal Endoscopic ImagerCystoscopy

Outcome Measures

Primary Outcomes (1)

  • Ergonomic comparaison of the two devices

    Ergonomic of the two devices will be evaluated and compared by using the scale NASA TLX (Hart SG, et al., 1998).

    1 day

Secondary Outcomes (4)

  • Comparison of performing time

    1 day

  • Quality assessment of image

    1 day

  • Quality assessment of device evaluation

    1 day

  • Evaluation of recording capacity of the video sequences to perform real-time image mosaics

    1 day

Study Arms (1)

Experimental

OTHER

Patients with a suspicion of a bladder cancer or suspected recurrence of bladder cancer will have a cystoscopy under their care. Patients will be randomized to know the order of carrying out cystoscopy with one or the other medical devices. 24 hours and 48 hours after the exam, a nurse will contact the patient to detect potential adverse effects

Device: Strorz (commercial)Device: CyPaM2 (experimental)

Interventions

Strorz (commercial)DEVICE
Experimental
CyPaM2 (experimental)DEVICE
Experimental

Eligibility Criteria

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

You may qualify if:

  • Age \>18 years
  • Patient with suspicion of a bladder cancer or a suspected recurrence of a bladder cancer
  • Cytological and bacteriological examination of urine culture negative
  • Patient must be affiliated to a social security system
  • Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

You may not qualify if:

  • Age \< 18 years
  • Bladder infection in progress and untreated
  • Hemorrhage
  • Urethral stenosis
  • Contraindication for a cystoscopy examination
  • Contraindication to administration of Hexvix (porphyria, hypersensitivity to hexylaminolévulinate or excipient of Hexvix (disodium phosphate dihydrate, potassium dihydrogen phosphate)
  • Pregnant or breast feeding females
  • Patients deprived of liberty or under supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

  • Amouroux M, Salleron J, Huin-Schohn C, Ali S, Berthaud S, Rizo P, Schneider S, Vever-Bizet C, Bourg-Heckly G, Guillemin F, Le Coupanec P, Galbrun E, Daouk J, Daul C, Blondel W, Eschwege P. Clinical evaluation of a device providing simultaneous white-light and fluorescence video streams as well as panoramic imaging during fluorescence assisted-transurethral resection of bladder cancer. J Opt Soc Am A Opt Image Sci Vis. 2019 Nov 1;36(11):C62-C68. doi: 10.1364/JOSAA.36.000C62.

    PMID: 31873695BACKGROUND

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

  • ESCHWEGE PASCAL, Pr

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 15, 2016

Study Start

July 4, 2016

Primary Completion

October 4, 2017

Study Completion

October 6, 2017

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)