Improving Sensitivity of Urine Cytology for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01826097
• Other study ID #: NA_00067544
• Status: Withdrawn
• Phase: N/A
• First received: April 1, 2013
• Last updated: January 30, 2018
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cancer Cells	Number of Cancer Cells in a 50 ml Urine	up to 24 weeks