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


Phase 0
18 Years
80 Years
Open (Enrolling)
Male
Bladder Cancer

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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 HospitalBaltimore, Maryland  21287