Ureteral CalculiURO-Y-2NCT01542593
Evaluating Ureteral Length Using Computed Tomography (CT)
A study testing Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR in people with Ureteral Calculi and Hydronephrosis, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ureteral Calculi, Hydronephrosis, Ureteral Obstruction
- What is being tested?
- Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to Mar 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing planned procedure involving ureteroscopy or ureteral stenting
- Abdominal CT scan performed within 6 months prior to intervention
Who cannot join
- Known iodine sensitivity
- Patients with fever or hemodynamic instability planned for urgent operation
- Severe immune compromized patients
- Severe thrombocytopenia < 50,000
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization
Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length.
Measurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting.
- Conditions
- Ureteral Calculi, Hydronephrosis, Ureteral Obstruction
- Being tested
- Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
- Medical subject headings
- Ureteral Calculi, Hydronephrosis, Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FRDevice
Also called Cook Urological Inc. open end ureteral catheter 5FR, Karl Storz cystoscope 19-22F
During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length.
Measurement results will be compared to measurements performed on CT scan (obtained before surgery).
| Study group | Role | What they receive |
|---|---|---|
| Ureteral catheterization | Experimental | During a planned procedure involving ureteroscopy or ureteral stenting, ureteral catheterization will be performed for the purpose of measuring exact ureteral length.
Measurement results will be compared to measurements performed on CT scan (obtained before surgery). Receives: Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuval Freifeld, Carmel Medical Center
- Investigators
- Yuval Freifeld, Dr., Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542593
- Sponsor's protocol ID
- CMC-11-0051-CTIL
- Acronym
- URO-Y-2
- Status last verified
- Apr 2015
- First submitted
- 16 Feb 2012
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization
- ClinicalTrials.gov ID
- NCT01542593
- Acronym / sponsor ID
- URO-Y-2 / CMC-11-0051-CTIL
- Conditions
- Ureteral Calculi, Hydronephrosis, Ureteral Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Mar 2012 (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.
Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length.
Measurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ureteral catheterization | Experimental | Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FRDuring a planned procedure involving ureteroscopy or ureteral stenting, ureteral catheterization will be performed for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing planned procedure involving ureteroscopy or ureteral stenting
- Abdominal CT scan performed within 6 months prior to intervention
Key exclusion criteria (4 listed)
- Known iodine sensitivity
- Patients with fever or hemodynamic instability planned for urgent operation
- Severe immune compromized patients
- Severe thrombocytopenia < 50,000
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 |
|---|---|---|
| Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FRAlso: Cook Urological Inc. open end ureteral catheter 5FR, Karl Storz cystoscope 19-22FDuring a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery). | Device | Ureteral catheterization |
Primary outcome
Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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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.
Yuval Freifeld, Dr. principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR in people with Ureteral Calculi and Hydronephrosis, run by Carmel 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 4 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: finished, as of the sponsor's last update on 30 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization (time frame: 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 30 Apr 2015.