Baacterial ColonizationNCT03090373
The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters
A study testing UroShield in people with Baacterial Colonization and Urinary Tract Infections, run by Rosenblum, Jonathan I., DPM at 1 site in United States.
Trial summary
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Baacterial Colonization, Urinary Tract Infections
- What is being tested?
- UroShield
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently being treated with an indwelling urinary catheter for at least 30 days.
- Ability to sign informed consent or have someone authorized to sign informed consent.
Who cannot join
- Currently being treated for an active Urinary Tract infection.
- Previous treatment with Surface Acoustic Waves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.
Read the detailed description
This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter.
Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device.
At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.
- Conditions
- Baacterial Colonization, Urinary Tract Infections
- Being tested
- UroShield
- Keywords
- Catheter, UTI's
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroShieldDevice
Also called Surface Acoustic Wave Actuator
The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | At catheter replacement subjects will have a sham UroShield device attached to the external portion of the catheter and have it activated for 30 days.
Standard of care for the upkeep and cleanliness of the catheter will be adhered to.
At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization. Receives: Device: UroShield |
| Treatment Group | Active comparator | At catheter replacement subjects will have an active UroShield device attached to the external portion of the catheter and have it activated for 30 days.
Standard of care for the upkeep and cleanliness of the catheter will be adhered to.
At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization. Receives: Device: UroShield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Colonization
Number of cultured colonies from both the Urinary Catheter and retained urine
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baacterial ColonizationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blinded, randomized controlled trial. All involved will be blinded as to whether the supplied UroShield device is active or a sham.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rosenblum, Jonathan I., DPM
- Collaborators
- Nanovibronix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090373
- Sponsor's protocol ID
- US-2
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will NOT be shared beyond the investigators of this study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
- ClinicalTrials.gov ID
- NCT03090373
- Acronym / sponsor ID
- US-2
- Conditions
- Baacterial Colonization, Urinary Tract Infections
- Keywords
- Catheter, UTI's
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Rosenblum, Jonathan I., DPM
- Collaborators
- Nanovibronix
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 24 Mar 2017 (actual)
- 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.
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.
Detailed description
This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter.
Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device.
At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double blinded, randomized controlled trial. All involved will be blinded as to whether the supplied UroShield device is active or a sham.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Device: UroShieldAt catheter replacement subjects will have a sham UroShield device attached to the external portion of the catheter and have it activated for 30 days. Standard of care for the upkeep and cleanliness of the catheter will be adhered to. At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization. |
| Treatment Group | Active comparator | Device: UroShieldAt catheter replacement subjects will have an active UroShield device attached to the external portion of the catheter and have it activated for 30 days. Standard of care for the upkeep and cleanliness of the catheter will be adhered to. At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently being treated with an indwelling urinary catheter for at least 30 days.
- Ability to sign informed consent or have someone authorized to sign informed consent.
Key exclusion criteria (2 listed)
- Currently being treated for an active Urinary Tract infection.
- Previous treatment with Surface Acoustic Waves.
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 |
|---|---|---|
| UroShieldAlso: Surface Acoustic Wave ActuatorThe UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects. | Device | Control Group, Treatment Group |
Primary outcome
Bacterial Colonization
Time frame: 30 days
Number of cultured colonies from both the Urinary Catheter and retained urine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: No. Data will NOT be shared beyond the investigators of this study.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroShield in people with Baacterial Colonization and Urinary Tract Infections, run by Rosenblum, Jonathan I., DPM 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Bacterial Colonization (time frame: 30 days). 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 24 Mar 2017.