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Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection (CyPaM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800473
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Device: Strorz (commercial) Device: CyPaM2 (experimental) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Comparison of performing time [ Time Frame: 1 day ]
    Performing time of medical examination with both devices will be evaluated and compared

  2. Quality assessment of image [ Time Frame: 1 day ]
    Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire.

  3. Quality assessment of device evaluation [ Time Frame: 1 day ]
    Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800473


Locations
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France
Institut de Cancerologie de Lorraine
Vandoeuvre-les-Nancy, France, 54519
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: ESCHWEGE PASCAL, Pr Institut de Cancérologie de Lorraine
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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02800473    
Other Study ID Numbers: 2015-A01297-42
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut de Cancérologie de Lorraine:
Bladder cancer
Hexvix
Bimodal Endoscopic Imager
Cystoscopy
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases