Bladder CancerCyPaM2NCT02800473
Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection
A study testing Strorz (commercial) and CyPaM2 (experimental) in people with Bladder Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Strorz (commercial) and CyPaM2 (experimental)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2016to 6 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)
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.
Read the detailed description
An innovative medical device was developped by the CyPaM2 project's partners.This device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. The medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. The main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.
- Conditions
- Bladder Cancer
- Being tested
- Strorz (commercial), CyPaM2 (experimental)
- Keywords
- Bladder cancer, Hexvix, Bimodal Endoscopic Imager, Cystoscopy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strorz (commercial)Device
CyPaM2 (experimental)Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Strorz (commercial); Device: CyPaM2 (experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (4)
Comparison of performing time
Performing time of medical examination with both devices will be evaluated and compared
Measured: 1 day
Quality assessment of image
Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire.
Measured: 1 day
Quality assessment of device evaluation
Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire
Measured: 1 day
Evaluation of recording capacity of the video sequences to perform real-time image mosaics
Recording capacity of the video sequences to perform real-time image mosaics will be assessed by the physician using a self-questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start4 Jul 2016
- Primary completion4 Oct 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ESCHWEGE PASCAL, Pr, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800473
- Sponsor's protocol ID
- 2015-A01297-42
- Acronym
- CyPaM2
- Status last verified
- Mar 2021
- First submitted
- 6 Jun 2016
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31873695
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)
- ClinicalTrials.gov ID
- NCT02800473
- Acronym / sponsor ID
- CyPaM2 / 2015-A01297-42
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Hexvix, Bimodal Endoscopic Imager, Cystoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An innovative medical device was developped by the CyPaM2 project's partners.This device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. The medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. The main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Device: Strorz (commercial), Device: CyPaM2 (experimental)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Age < 18 years
- Bladder infection in progress and untreated
- Hemorrhage
- Urethral stenosis
- Contraindication for a cystoscopy examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strorz (commercial) | Device | Experimental |
| CyPaM2 (experimental) | Device | Experimental |
Primary outcome
Ergonomic comparaison of the two devices
Time frame: 1 day
Ergonomic of the two devices will be evaluated and compared by using the scale NASA TLX (Hart SG, et al., 1998).
4 secondary outcomes
Comparison of performing time
Time frame: 1 day
Quality assessment of image
Time frame: 1 day
Quality assessment of device evaluation
Time frame: 1 day
Evaluation of recording capacity of the video sequences to perform real-time image mosaics
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 31873695Amouroux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESCHWEGE PASCAL, Pr principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strorz (commercial) and CyPaM2 (experimental) in people with Bladder Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ergonomic comparaison of the two devices (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.