InfectiousNCT02412891
Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
A study testing UroShield device in people with Infectious, run by HaEmek Medical Center, Israel.
Trial summary
Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage. The use of urinary catheters is a common medical practice in the perioperative setting. As such, it exposes the patient to certain comorbidities, including urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious
- What is being tested?
- UroShield device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.
Who cannot join
- Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.
- patients with a urinary tract infection in the past year.
- Patients with a urinary tract infection when inserting a catheter.
- pregnant women.
- Patients under the age of 18.
- without judgment.
About this study
Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.
The use of urinary catheters is a common medical practice in the perioperative setting.
As such, it exposes the patient to certain comorbidities, including urinary tract infections.
The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.
Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.
- Conditions
- Infectious
- Being tested
- UroShield device, Sham UroShield device
- Keywords
- introduction of urinary catheter
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroShield deviceDevice
The UroShield device is Consists of two units:Actuator and Driver.
Sham UroShield deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients receive active UroShield device | Active comparator | Patients receive active UroShield device Receives: Device: UroShield device |
| Patients receive inactive UroShield device | Sham comparator | Patients receive inactive UroShield device Receives: Device: Sham UroShield device |
What is being measured
The primary outcome is the main question the study is designed to answer.
side effects and complications of urinary catheter usage
the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Cancelled due to financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectiousStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412891
- Sponsor's protocol ID
- 0116-14-EMC
- Status last verified
- Sep 2016
- First submitted
- 1 Apr 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
- ClinicalTrials.gov ID
- NCT02412891
- Acronym / sponsor ID
- 0116-14-EMC
- Conditions
- Infectious
- Keywords
- introduction of urinary catheter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled due to financial reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 9 Apr 2015 (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.
Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.
The use of urinary catheters is a common medical practice in the perioperative setting.
As such, it exposes the patient to certain comorbidities, including urinary tract infections.
The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.
Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receive active UroShield device | Active comparator | Device: UroShield devicePatients receive active UroShield device |
| Patients receive inactive UroShield device | Sham comparator | Device: Sham UroShield devicePatients receive inactive UroShield device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.
Key exclusion criteria (6 listed)
- Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.
- patients with a urinary tract infection in the past year.
- Patients with a urinary tract infection when inserting a catheter.
- pregnant women.
- Patients under the age of 18.
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 |
|---|---|---|
| UroShield deviceThe UroShield device is Consists of two units:Actuator and Driver. | Device | Patients receive active UroShield device |
| Sham UroShield device | Device | Patients receive inactive UroShield device |
Primary outcome
side effects and complications of urinary catheter usage
Time frame: One Year
the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse
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 29 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing UroShield device in people with Infectious, run by HaEmek Medical Center, 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 1 inclusion and 6 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
side effects and complications of urinary catheter usage (time frame: One Year). 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 29 Sep 2016.