NCT02340650CompletedNot Applicable
High Resolution Imaging for Early and Better Detection of Bladder Cancer
The University of Texas Health Science Center, Houston1 site in 1 country37 target enrollmentStarted: April 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Specificity of Bladder Cancer Detection Imaging
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Specificity of Bladder Cancer Detection Imaging
Time Frame: baseline (at the time of imaging)
Secondary Outcomes
No secondary outcomes reported
Investigators
Nadeem N Dhanani
Assistant Professor
The University of Texas Health Science Center, Houston
Study Sites (1)
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