High Resolution Imaging for Early and Better Detection of Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bladder Cancer Patients

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.

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

Other Intervention Names

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HRME and/or LSC-HRME

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No