Urinary Tract InfectionNV-US-04-001NCT00702286
Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters
An observational study of Urinary Tract Infection, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Catheter associated urinary tract infection is one of the most common types of catheter acquired infections and adds greatly to patient morbidity, mortality and medical cost. Urinary catheters may readily acquire biofilms when inserted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to not given
- Phase
- Observational
- 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
Study population: All Patients requiring percoutaneous nephrostome drainage for period for more then 4 weeks
Who may be able to join
- Patients requiring percoutaneous nephrostome
- First insertion
Who cannot join
- Blood coagulation disorders
- Trauma
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh MC
Tsrifin, Isarel, 40700
Yoram I Siegel, MD, 972-8-9779400, yoram.siegel @gamil.com
Amir Peer, MD, 972-8-9779483
About this study
Official title: Phase II Prospective Comparison Randomized Placebo Controlled Double Blind Study to Evaluate the Efficacy of the UroShieldTM Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy
Catheter associated urinary tract infection is one of the most common types of catheter acquired infections and adds greatly to patient morbidity, mortality and medical cost. Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains in place, the greater the tendency of these organisms to develop biofilms and result in urinary tract infections, which are difficult to treathe UroShield System is intended to prevent bacterial biofilm formation by means of the Active NanoShield technology it has developed. A number of scientific concepts and principles shown in prior studies have shown some promising results in the treatment of biofilm based sequele using ultrasound energy. The NanoShield technological basis of the UroShield System has taken these concepts to a level where acoustical waves in the ultrasound range can be created by low cost disposable actuators which actually create a physical coating on all of the surfaces of the catheter thereby interfering with the attachment of bacteria which is the initial step in biofilm formation.
Read the detailed description
The UroShield™ System is comprised of 2 main components:· The Disposable UroShield Z-Patch - a disposable small lightweight patch that is attached to the PCN catheter, while its opposite side is attached directly to the patient's skin at the site of catheter entry. The patch has twofold function:
- it receives energy and a signal from the UroShield Driver allowing it to generate the ultrasonic waves;
- it acts as a fixation device for the PCN catheter.· The UroShield Driver - an external driver unit that is attached to the UroShield patch and contains batteries to power the system and electronics that control the patch unit
- Conditions
- Urinary Tract Infection
- Keywords
- Surface acoustic ultrasound, biofilm formation, percoutaneous nephrostomy tube, Patients requiring per coetaneous drainage due to urinary, tract obstruction, To evaluate the efficacy of surface acoustic wave in, reducing pain and improving drainage
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study | |
| 2 | Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency.
Measured: 28 days for one subject overall 1 year
Secondary outcomes (1)
Renal function improvement
Measured: 28 days per pateint overall 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startAug 2008
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Nanovibronix
- Investigators
- Yoram I Siegel, MD, Principal investigator, Assaf Harofeh MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702286
- Sponsor's protocol ID
- 75/08
- Acronym
- NV-US-04-001
- Status last verified
- May 2008
- First submitted
- 17 Jun 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Comparison Randomized Placebo Controlled Double Blind Study to Evaluate the Efficacy of the UroShieldTM Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy
- ClinicalTrials.gov ID
- NCT00702286
- Acronym / sponsor ID
- NV-US-04-001 / 75/08
- Conditions
- Urinary Tract Infection
- Keywords
- Surface acoustic ultrasound, biofilm formation, percoutaneous nephrostomy tube, Patients requiring per coetaneous drainage due to urinary, tract obstruction, To evaluate the efficacy of surface acoustic wave in, reducing pain and improving drainage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Nanovibronix
- Study start
- Aug 2008
- First posted
- 20 Jun 2008 (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.
Catheter associated urinary tract infection is one of the most common types of catheter acquired infections and adds greatly to patient morbidity, mortality and medical cost. Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains in place, the greater the tendency of these organisms to develop biofilms and result in urinary tract infections, which are difficult to treathe UroShield System is intended to prevent bacterial biofilm formation by means of the Active NanoShield technology it has developed. A number of scientific concepts and principles shown in prior studies have shown some promising results in the treatment of biofilm based sequele using ultrasound energy. The NanoShield technological basis of the UroShield System has taken these concepts to a level where acoustical waves in the ultrasound range can be created by low cost disposable actuators which actually create a physical coating on all of the surfaces of the catheter thereby interfering with the attachment of bacteria which is the initial step in biofilm formation.
Detailed description
The UroShield™ System is comprised of 2 main components:· The Disposable UroShield Z-Patch - a disposable small lightweight patch that is attached to the PCN catheter, while its opposite side is attached directly to the patient's skin at the site of catheter entry. The patch has twofold function:
- it receives energy and a signal from the UroShield Driver allowing it to generate the ultrasonic waves;
- it acts as a fixation device for the PCN catheter.· The UroShield Driver - an external driver unit that is attached to the UroShield patch and contains batteries to power the system and electronics that control the patch unit
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study |
| 2 | – | –Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients requiring percoutaneous nephrostome drainage for period for more then 4 weeks
Key inclusion criteria (2 listed)
- Patients requiring percoutaneous nephrostome
- First insertion
Key exclusion criteria (2 listed)
- Blood coagulation disorders
- Trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency.
Time frame: 28 days for one subject overall 1 year
1 secondary outcome
Renal function improvement
Time frame: 28 days per pateint overall 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
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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.
Yoram I Siegel, MD principal investigator
Assaf Harofeh MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection, run by Assaf-Harofeh Medical Center 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 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 20 Jun 2008. 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.
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 Yoram I Siegel, MD (972-8-9779400, yoram.siegel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency. (time frame: 28 days for one subject overall 1 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 20 Jun 2008.