High Resolution Imaging for Early and Better Detection of Bladder Cancer

The University of Texas Health Science Center, Houston37 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Cancer

Interventions

Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution MicroendoscopeDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Specificity of Bladder Cancer Detection Imaging

Time frame: baseline (at the time of imaging)

Data from ClinicalTrials.gov

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