High Resolution Imaging for Early and Better Detection of Bladder Cancer (HRME_Bladder)

The University of Texas System (UT)

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope

Study type: Observational

Funder types: Other

Identifiers

NCT02340650

HSC-MS-14-0144

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

37 participants in 1 patient group

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.

Treatment:

Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope