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NCT02340650 Clinical Trial

High Resolution Imaging for Early and Better Detection of Bladder Cancer

Bladder Cancer Clinical Trial

— HRME_Bladder  

Official title:
High Resolution Imaging for Early and Better Detection of Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02340650
Other study ID # HSC-MS-14-0144
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2015
Est. completion date September 30, 2020

Study information
Verified date June 2021
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Lyndon B. Johnson General Hospital Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Specificity of Bladder Cancer Detection Imaging baseline (at the time of imaging)
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