Improving Sensitivity of Urine Cytology for Bladder Cancer | NCT01826097

Studies
Improving Sensitivity of Urine Cytology for Bladder Cancer

NCT01826097

Sponsor

Johns Hopkins University

Status

Withdrawn

Last Update Posted

Feb 1, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Bladder Cancer

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 1, 2013

First Submission Date that Met QC Criteria

Apr 3, 2013

First Posted Date

Apr 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Feb 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vibration	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration	Device		Vibration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Cancer Cells	Number of Cancer Cells in a 50 ml Urine	up to 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trinity Bivalacqua, MD/PhD	Johns Hopkins University	Principal Investigator
John J Kim, BS	Johns Hopkins University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided