Kidney DiseaseJJVsPCN08NCT00739284
A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney
A study testing nephrostomy tube and ureteral stent in people with Kidney Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease
- What is being tested?
- nephrostomy tube and ureteral stent
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Aug 2008
- 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
None listed.
Who cannot join
- Patients with medical condition that prevent the use of one of the procedures
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin medical center
Petah Tikva
Shay Golan, MD, 972-3-9376560, shayg@clalit.org.il
Shay Golan, MD
About this study
Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.
- Conditions
- Kidney Disease
- Being tested
- nephrostomy tube and ureteral stent
- Keywords
- preferred, procedure, drainage, obstructed, kidney, stone
- Medical subject headings
- Kidney Diseases, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nephrostomy tube and ureteral stentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739284
- Sponsor's protocol ID
- JJVsPCN08
- Acronym
- JJVsPCN08
- Status last verified
- Aug 2008
- First submitted
- 20 Aug 2008
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney
- ClinicalTrials.gov ID
- NCT00739284
- Acronym / sponsor ID
- JJVsPCN08 / JJVsPCN08
- Conditions
- Kidney Disease
- Keywords
- preferred, procedure, drainage, obstructed, kidney, stone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2008 (estimated)
- First posted
- 21 Aug 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.
Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with medical condition that prevent the use of one of the procedures
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 |
|---|---|---|
| nephrostomy tube and ureteral stent | Device | – |
Primary outcome
quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nephrostomy tube and ureteral stent in people with Kidney Disease, run by Rabin 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 0 inclusion and 1 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 21 Aug 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 Shay Golan, MD (972-3-9376560, shayg@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life. 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 21 Aug 2008.