Bladder CancerNCT01826097
Improving Sensitivity of Urine Cytology for Bladder Cancer
A study testing La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration in people with Bladder Cancer, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Pacemaker
- Epilepsy
- Musculo-skeletal disorders
- Weight in excess of 250 pounds
- Poor circulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
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.
- Conditions
- Bladder Cancer
- Being tested
- La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration
- Keywords
- Cytology, Whole body massage vibration
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell ConcentrationDevice
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | Whole body vibration applied to a group of 20 bladder cancer patients. Receives: Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cancer Cells
Number of Cancer Cells in a 50 ml Urine
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trinity Bivalacqua, MD/PhD, Principal investigator, Johns Hopkins UniversityJohn J Kim, BS, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826097
- Sponsor's protocol ID
- NA_00067544
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2013
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
- ClinicalTrials.gov ID
- NCT01826097
- Acronym / sponsor ID
- NA_00067544
- Conditions
- Bladder Cancer
- Keywords
- Cytology, Whole body massage vibration
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibration | Experimental | Device: La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell ConcentrationWhole body vibration applied to a group of 20 bladder cancer patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration | Device | Vibration |
Primary outcome
Number of Cancer Cells
Time frame: up to 24 weeks
Number of Cancer Cells in a 50 ml Urine
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trinity Bivalacqua, MD/PhD principal investigator
Johns Hopkins University
John J Kim, BS study chair
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration in people with Bladder Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cancer Cells (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.