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OpenTrials
Completed

NCT Number: NCT02340650

High Resolution Imaging for Early and Better Detection of Bladder Cancer

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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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Other names: HRME and/or LSC-HRME

Primary outcomes

  1. Specificity of Bladder Cancer Detection Imaging

    Time frame: baseline (at the time of imaging)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • William Marsh Rice University

Registry information

Acronym: HRME_Bladder

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2015
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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