Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection (CyPaM2)
|ClinicalTrials.gov Identifier: NCT02800473|
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: Strorz (commercial) Device: CyPaM2 (experimental)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||July 4, 2016|
|Actual Primary Completion Date :||October 4, 2017|
|Actual Study Completion Date :||October 6, 2017|
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)
- 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).
- Comparison of performing time [ Time Frame: 1 day ]Performing time of medical examination with both devices will be evaluated and compared
- Quality assessment of image [ Time Frame: 1 day ]Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire.
- Quality assessment of device evaluation [ Time Frame: 1 day ]Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire
- Evaluation of recording capacity of the video sequences to perform real-time image mosaics [ Time Frame: 1 day ]Recording capacity of the video sequences to perform real-time image mosaics will be assessed by the physician using a self-questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800473
|Institut de Cancerologie de Lorraine|
|Vandoeuvre-les-Nancy, France, 54519|
|Principal Investigator:||ESCHWEGE PASCAL, Pr||Institut de Cancérologie de Lorraine|