Houston, Texas 77026


Purpose:

This is a pilot study involving 100 subjects. The primary aim will be to conduct image analysis with the use of High resolution micro-endoscope on the profile of normal bladder tissue, inflamed bladder tissue, suspicious bladder tissue and bladder cancer tissues . The secondary aim will be to examine the effectiveness of the new (HRME) device for early diagnosis of bladder cancer with less invasive procedure. This is a pilot study examining imaging analysis in patients with normal bladder tissue, inflamed bladder tissue, suspicious bladder tissue, and bladder cancer who are scheduled to have cystoscopy. This is a cross sectional study therefore, each patient will participate only once in this study. The study involves only 1 visit: Visit #1: schedules cystoscopy and biopsy procedure that are part of standard care and then capturing image with the use of HRME device as a part of research procedure. All the procedures performed in this study are normally done in the work-up of patients scheduled to have cystoscopy procedure and is considered a routine procedure for bladder cancer screening. The only procedure/treatment which is not routine is the use of High resolution microendoscope. Biopsy will be taken at the time of cystoscopy that involves standard of care. Images taken by HRME device will then be correlated with pathology results of the biopsied tissue. The samples will be coded and de-identified data will be sent to Dr. Kortum's laboratory for correlation. The blood and urine samples collected during the screening visit are routine tests for patients with bladder cancer and will be handled according to standard of practice. The test results will be included in the subject's research and medical charts. Additional research related information will be provided at the end of the study. Risks include those related to cystoscopy and HRME device may include infection, pain, difficulty with urination and blood in urine, perforation. Potential benefits may include to this subject class for early detection of bladder cancer with minimal invasive technique. Understanding the effects of HRME device on the bladder screening may improve screening and detection methodologies for future patients with bladder cancer.


Criteria:

A. Inclusion Criteria All participants in this study will be chosen independent of age, sex, and ethnic background meeting following criteria: 1. Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystocopy as part of their routine clinical care. 2. Age 18 years and older 3. Must be willing and able to participate and provide written informed consent 4. Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation B. Exclusion Criteria A patient will be excluded if: 1. 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. 2. Women with the possibility of having the pregnancy. 3. Patients having acute infection. 4. Person with Lidocaine sensitivity.


NCT ID:

NCT02340650


Primary Contact:

Principal Investigator
Nadeem N Dhanani, MD MPH
The University of Texas Health Science Center, Houston

Nadeem N Dhanani, MD MPH
Phone: (713) 500-7337
Email: Nadeem.N.Dhanani@uth.tmc.edu


Backup Contact:

Email: Comalita.Lee@UTH.TMC.EDU
Comalita L. Lee, CRC, BAAS
Phone: 713.500.6086


Location Contact:

Houston, Texas 77026
United States

Nadeem Dhanani, MD, MPH
Phone: 713-500-7337

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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