Trial Information
Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Screening
Outcome Measure:
Number of Cancer Cells
Outcome Description:
Number of Cancer Cells in a 50 ml Urine
Outcome Time Frame:
up to 24 weeks
Safety Issue:
No
Principal Investigator
Trinity Bivalacqua, MD/PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
J1236
NCT ID:
NCT01826097
Start Date:
January 2013
Completion Date:
January 2014
Related Keywords:
- Bladder Cancer
- Cytology
- Whole body massage vibration
- Urinary Bladder Neoplasms
Name | Location |
Johns Hopkins Hospital |
Baltimore, Maryland 21287 |