Urinary Tract InfectionPhase 2/3CAUTINCT00446732
The Use of the UroShield Device in Patients With Indwelling Urinary Catheters
A Phase 2/3 study testing UroSshield in people with Urinary Tract Infection, run by Nanovibronix at 1 site in Israel.
Trial summary
According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- UroSshield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Jun 2009
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients age 18 years or older
- Patients requiring or having catheterization for more than 24 hours
- Patient able, agrees and signs the Informed Consent Form
Who cannot join
- Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study
- Presence of any clinically relevant known urinary tract infection
- Patient with condition who is not expected to survive the study period
- Known HIV positive
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Patient is currently participating in another clinical study.
- Known allergy to latex
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem
Ofer Shenfeld, MD
About this study
Official title: Catheter Associated Urinary Tract Infections
According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.
Read the detailed description
This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization.
- Primary objectives
- To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters
- Pain
- Discomfort
- To observe the effect of UroShield in the reduction/prevention of Biofilm
- To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters
- Safety Objective To assess the safety parameters of the UroShield system
- Secondary Objectives
- To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters
- To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter
- To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter
- To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter
- Conditions
- Urinary Tract Infection
- Being tested
- UroSshield
- 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.
UroSshieldDevice
Attachment of the UroShield device to the external part of the urinary catheter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: UroSshield |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary end points
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanovibronix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shaare Zedek Medical Center
- Investigators
- Ofer Shenfeled, MD, Principal investigator, Sharei Zedek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446732
- Sponsor's protocol ID
- US-71-003
- Acronym
- CAUTI
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Associated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT00446732
- Acronym / sponsor ID
- CAUTI / US-71-003
- Conditions
- Urinary Tract Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NanovibronixIndustry (pharma, biotech, devices)
- Collaborators
- Shaare Zedek Medical Center
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 13 Mar 2007 (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.
According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.
Detailed description
This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization.
- Primary objectives
- To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters
- Pain
- Discomfort
- To observe the effect of UroShield in the reduction/prevention of Biofilm
- To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters
- Safety Objective To assess the safety parameters of the UroShield system
- Secondary Objectives
- To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters
- To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter
- To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter
- To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: UroSshield |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized patients age 18 years or older
- Patients requiring or having catheterization for more than 24 hours
- Patient able, agrees and signs the Informed Consent Form
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study
- Presence of any clinically relevant known urinary tract infection
- Patient with condition who is not expected to survive the study period
- Known HIV positive
- Patient has any condition, which precludes compliance with study and/or device instructions.
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 |
|---|---|---|
| UroSshieldAttachment of the UroShield device to the external part of the urinary catheter | Device | 1 |
Primary outcome
primary end points
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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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.
Ofer Shenfeled, MD principal investigator
Sharei Zedek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing UroSshield in people with Urinary Tract Infection, run by Nanovibronix at 1 site in Israel.
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 7 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 25 Mar 2009. 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 Israel. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ofer Shenfeld, MD (972-2-6555560, shenfeld@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary end points (time frame: up to 14 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 25 Mar 2009.