Bladder Cancer
Conditions
Keywords
suspicious bladder lesion, normal bladder tissue
Brief summary
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.
Interventions
DEVICEStandard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope
Sponsors
William Marsh Rice University
The University of Texas Health Science Center, Houston
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity of Bladder Cancer Detection Imaging | baseline (at the time of imaging) |
Countries
United States
Outcome results
None listed