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Improving Sensitivity of Urine Cytology for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826097
Recruitment Status : Withdrawn
First Posted : April 8, 2013
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Can a commercially available vibrating chair increase the number of urothelial cells in a urine sample of healthy participants non-invasively? The investigators plan is participants will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour. Then, urine samples will be collected and examined for urothelial cell concentration for both groups.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Screening
Official Title: Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
Actual Study Start Date : January 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vibration
Whole body vibration applied to a group of 20 bladder cancer patients.
Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration



Primary Outcome Measures :
  1. Number of Cancer Cells [ Time Frame: up to 24 weeks ]
    Number of Cancer Cells in a 50 ml Urine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only adult male subjects who will not have surgery within a period of 2 weeks.
  • Over the age of 18
  • Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days

Exclusion Criteria:

  • Cognitive impairment resulting in the inability to give informed consent
  • Lack of spoken and written English resulting in the inability to give informed consent
  • Presence of infectious disease
  • Insulin dependent diabetes mellitus
  • Endogenous osteosynthetical material implants
  • Knee or hip prosthesis
  • Pacemaker
  • Epilepsy
  • Musculo-skeletal disorders
  • Weight in excess of 250 pounds
  • Poor circulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826097


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Trinity Bivalacqua, MD/PhD Johns Hopkins University
Study Chair: John J Kim, BS Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01826097    
Other Study ID Numbers: NA_00067544
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Keywords provided by Johns Hopkins University:
Cytology
Whole body massage vibration
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases