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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Ergonomic comparaison of the two devices
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)