High Resolution Imaging for Early and Better Detection of Bladder Cancer

Completed

• Conditions: Bladder Cancer
• Interventions: Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope

• Registration Number: NCT02340650
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-16
• Study Start: 2015-04
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder Cancer Patients	Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope	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.

Primary Outcome Measures

Name	Time	Method
Specificity of Bladder Cancer Detection Imaging	baseline (at the time of imaging)

Trial Locations

Locations (1)

Lyndon B. Johnson General Hospital; 🇺🇸 Houston, Texas, United States