Clinical trial · Observational
High Resolution Imaging for Early and Better Detection of Bladder Cancer
NCT02340650CI-TRIAL-00052439HRME_BladdercompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to develop, optimize, and validate a High Resolution Imaging System in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bladder Cancer Patients
- description
- High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.
- interventionNames
- Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope
Primary outcomes (1)
- measure
- Specificity of Bladder Cancer Detection Imaging
- timeFrame
- baseline (at the time of imaging)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care. * Must be willing and able to participate and provide written informed consent * Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation Exclusion Criteria: * Patient with sufficient evidence of cognitive impairment that limits the subject's ability to understand the protocol, provide informed consent, or to comply with the protocol procedures. * Women with the possibility of having the pregnancy. * Patients having acute infection. * Person with Lidocaine sensitivity.
References
Publications (1)
- DERIVEDTang Y, Kortum A, Vohra I, Schwarz RA, Carns J, Kannady CR, Clavell-Hernandez J, Hu Z, Dhanani N, Richards-Kortum R. Initial Results of First In Vivo Imaging of Bladder Lesions Using a High-Resolution Confocal Microendoscope. J Endourol. 2021 Aug;35(8):1190-1197. doi: 10.1089/end.2020.0757. Epub 2021 Jan 21. PMID 33307957