HematuriaUROVISIONCT02276924
Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors
A study testing Laser confocal microscopy in people with Hematuria and Nephrolithiasis, run by Lille Catholic University at 1 site in France.
Trial summary
Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematuria, Nephrolithiasis, Cancer of Urinary Tract
- What is being tested?
- Laser confocal microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Oct 2016
- 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
- Any legally adult fully informed patient who consent to participate to the study
- Patient followed by the Urology Department
- Indication for a diagnosis or treatment reno-ureteroscopy
- Coverage of the social insurance
Who cannot join
- Minor Patient
- Pregnancy or breast feeding
- Concomitant treatment (for example beta-blocker)
- Contra-indication to general anaesthesia
- Hypersensitivity to sodium fluorescein
- Medical history of cardio-pulmonary disease (myocardial infarction, cardiovascular event, bronchospasm ...) due to fluorescein instillation
- Medical history of asthma or allergy due to fluorescein instillation
Trial locations and contacts
1 site in 1 country.
France1 site
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, 59000
About this study
Official title: Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors
Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.
Read the detailed description
The objective of the present study is to assess contribution of laser confocal microscopy in diagnosing of upper urinary tract tumors during a reno-uteroscopy compared to analysing of architectural elements (vascular characteristics, organization) and cellular (morphology, cohesion, border).
- Being tested
- Laser confocal microscopy
- Keywords
- Laser Confocal Microscopy, Superior Urinary Tract Tumors
- Medical subject headings
- Hematuria, Nephrolithiasis, Urologic Neoplasms, Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser confocal microscopyDevice
Also called Cell-vizio
Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will receive an intra-vesical instillation of fluorescein (0.1%) for 5 minutes, followed by the laser confocal microscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Laser confocal microscopy | Experimental | Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure. Receives: Device: Laser confocal microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria
According to Chang's reference criteria, we will define the urothelial microarchitecture (normal, papillary, inflammatory, low grade lesion, high grade lesion, in situ carcinoma). The diagnostic relevance of the MCL (absence or presence of the lesion) will be compare to the reference tests calculating sensibility, specificity and predictive values
Measured: 24 months
Secondary outcomes (3)
Inter- and intra-observer diagnostic concordance
Anonymized videos of the intervention will be reviewed at the end of the study by a "naive" surgeon to assess inter-observer concordance. A concordance Kappa test will be performed
Measured: 24 months
Surgery duration
Measured: 24 months
Reference atlas
Videos and images quality will be assessed to compile them in a refence atlas
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
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 HematuriaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Bonnal, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276924
- Sponsor's protocol ID
- RC-P0026
- Acronym
- UROVISIO
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2014
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Marien A, Rock A, Maadarani KE, Francois C, Gosset P, Mauroy B, Bonnal JL. Urothelial Tumors and Dual-Band Imaging: A New Concept in Confocal Laser Endomicroscopy. J Endourol. 2017 May;31(5):538-544. doi: 10.1089/end.2016.0892. Epub 2017 Mar 22.
PubMed 28326794
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors
- ClinicalTrials.gov ID
- NCT02276924
- Acronym / sponsor ID
- UROVISIO / RC-P0026
- Keywords
- Laser Confocal Microscopy, Superior Urinary Tract Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Oct 2014 (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.
Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.
Detailed description
The objective of the present study is to assess contribution of laser confocal microscopy in diagnosing of upper urinary tract tumors during a reno-uteroscopy compared to analysing of architectural elements (vascular characteristics, organization) and cellular (morphology, cohesion, border).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser confocal microscopy | Experimental | Device: Laser confocal microscopyPatients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any legally adult fully informed patient who consent to participate to the study
- Patient followed by the Urology Department
- Indication for a diagnosis or treatment reno-ureteroscopy
- Coverage of the social insurance
Key exclusion criteria (7 listed)
- Minor Patient
- Pregnancy or breast feeding
- Concomitant treatment (for example beta-blocker)
- Contra-indication to general anaesthesia
- Hypersensitivity to sodium fluorescein
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 |
|---|---|---|
| Laser confocal microscopyAlso: Cell-vizioPatients undergoing a reno-ureteroscopy for diagnosis or treatment indication will receive an intra-vesical instillation of fluorescein (0.1%) for 5 minutes, followed by the laser confocal microscopy procedure. | Device | Laser confocal microscopy |
Primary outcome
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria
Time frame: 24 months
According to Chang's reference criteria, we will define the urothelial microarchitecture (normal, papillary, inflammatory, low grade lesion, high grade lesion, in situ carcinoma). The diagnostic relevance of the MCL (absence or presence of the lesion) will be compare to the reference tests calculating sensibility, specificity and predictive values
3 secondary outcomes
Inter- and intra-observer diagnostic concordance
Time frame: 24 months
Surgery duration
Time frame: 24 months
Reference atlas
Time frame: 24 months
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 24 Dec 2025.
- Results publication: PubMed 28326794Marien A, Rock A, Maadarani KE, Francois C, Gosset P, Mauroy B, Bonnal JL. Urothelial Tumors and Dual-Band Imaging: A New Concept in Confocal Laser Endomicroscopy. J Endourol. 2017 May;31(5):538-544. doi: 10.1089/end.2016.0892. Epub 2017 Mar 22.
Related trials for Hematuria
Active, not recruitingObservational study
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Urothelial Carcinoma
RecruitingObservational study
Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population
UTUC, UC (Urothelial Cancer)
Not yet recruitingPhase 3
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
Recruiting
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
Hematuria - Cause Not Known
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.
Jean-Louis Bonnal, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser confocal microscopy in people with Hematuria and Nephrolithiasis, run by Lille Catholic University 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 4 inclusion and 7 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 24 Dec 2025. 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?
Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria (time frame: 24 months). 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 NCT02276924, 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 24 Dec 2025.