UreterolithiasisNCT02279927
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy
A study testing Ureteroscopy in people with Ureterolithiasis and Nephrolithiasis, run by Carmel Medical Center at 1 site in Israel.
Trial summary
A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureterolithiasis, Nephrolithiasis
- What is being tested?
- Ureteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are planned for ureteroscopy \ retrograde intra renal surgery (RIRS) for stone treatment
Who cannot join
- known ureteral stricture
- severe immune deficiency
- patients after urinary diversion surgery
- patients with single \ ectopic\ implanted kidney
- double collecting system
- severe thrombocytopenia
- patients taking anticoagulant drugs that cannot be stooped before the operation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa
Yuval Freifeld, +97248250843, yuvalfr@clalit.org.il
Yuval Freifeld, MD
About this study
Official title: Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During
A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy
Read the detailed description
Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments
- Conditions
- Ureterolithiasis, Nephrolithiasis
- Being tested
- Ureteroscopy
- Keywords
- Ureteroscopy
- Medical subject headings
- Ureterolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreteroscopyDevice
Ureteroscopy with laser stone fragmentation
| Study group | Role | What they receive |
|---|---|---|
| Low energy high frequency | Experimental | Ureteroscopy with laser settings of low energy \& high frequency with aim of stone dusting Receives: Device: Ureteroscopy |
| High energy low frequency | Active comparator | Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments Receives: Device: Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Measured: 1 month
Secondary outcomes (1)
Duration of operation
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreterolithiasisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuval Freifeld, Principal investigator, Carmel MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279927
- Sponsor's protocol ID
- CMC-14-0063-CTIL
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During
- ClinicalTrials.gov ID
- NCT02279927
- Acronym / sponsor ID
- CMC-14-0063-CTIL
- Conditions
- Ureterolithiasis, Nephrolithiasis
- Keywords
- Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Oct 2014 (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.
A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy
Detailed description
Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low energy high frequency | Experimental | Device: UreteroscopyUreteroscopy with laser settings of low energy \& high frequency with aim of stone dusting |
| High energy low frequency | Active comparator | Device: UreteroscopyUreteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments |
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 are planned for ureteroscopy \ retrograde intra renal surgery (RIRS) for stone treatment
Key exclusion criteria (7 listed)
- known ureteral stricture
- severe immune deficiency
- patients after urinary diversion surgery
- patients with single \ ectopic\ implanted kidney
- double collecting system
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 |
|---|---|---|
| UreteroscopyUreteroscopy with laser stone fragmentation | Device | High energy low frequency, Low energy high frequency |
Primary outcome
Stone free rate
Time frame: 1 month
1 secondary outcome
Duration of operation
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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 principal investigator
Carmel MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy in people with Ureterolithiasis and Nephrolithiasis, 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 1 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 31 Oct 2014. 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 Yuval Freifeld (+97248250843, yuvalfr@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: 1 month). 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 31 Oct 2014.