NephrolithiasisPhase 4NCT02443909
Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery
A Phase 4 study testing Retrograde Intrarenal Surgery and Holmium laser device in people with Nephrolithiasis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Retrograde Intrarenal Surgery and Holmium laser device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Jan 2017
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have 2-3 cm kidney stones
- patients who are between 18-90 years old
Who cannot join
- patients who have congenital urogenital abnormalities
- patients who have previous surgery history for urinary stones
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital
Ankara, 06110
Nihat Karakoyunlu, MD, 00905324747134, nkarakoyunlu@gmail.com
Nihat Karakoyunlu, MD
About this study
To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).
- Conditions
- Nephrolithiasis
- Being tested
- Retrograde Intrarenal Surgery, Holmium laser device
- Keywords
- Holmium Laser, Kidney Stones, RIRS
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intrarenal SurgeryProcedure or surgery
Also called RIRS
endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
Retrograde Intrarenal SurgeryProcedure or surgery
Also called RIRS
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
Retrograde Intrarenal SurgeryProcedure or surgery
Also called RIRS
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Holmium laser deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| first group | Active comparator | Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones Receives: Procedure: Retrograde Intrarenal Surgery; Device: Holmium laser device |
| second group | Active comparator | Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones Receives: Procedure: Retrograde Intrarenal Surgery; Device: Holmium laser device |
| third group | Active comparator | Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston Receives: Procedure: Retrograde Intrarenal Surgery; Device: Holmium laser device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Complications according to clavien system)
Complications according to clavien system
Measured: 1 day
Efficiency (visual analog score)
visual analog score
Measured: 1 Day
Secondary outcomes (1)
Efficiency (stone free rate)
stone free rate/
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihat Karakoyunlu, Diskapi Teaching and Research Hospital
- Investigators
- Nihat Karakoyunlu, MD, Principal investigator, Ministry of Health, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443909
- Sponsor's protocol ID
- 26.01.2015
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Redondo C, Ramon de Fata F, Gimbernat H, Meilan E, Andres G, Angulo JC. Retrograde intrarenal surgery with holmium-YAG laser lithotripsy in the primary treatment of renal lithiasis. Actas Urol Esp. 2015 Jun;39(5):320-6. doi: 10.1016/j.acuro.2014.06.004. Epub 2014 Oct 25. English, Spanish.
PubMed 25443519
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT02443909
- Acronym / sponsor ID
- 26.01.2015
- Conditions
- Nephrolithiasis
- Keywords
- Holmium Laser, Kidney Stones, RIRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 May 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.
To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| first group | Active comparator | Procedure: Retrograde Intrarenal Surgery, Device: Holmium laser devicePatients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones |
| second group | Active comparator | Procedure: Retrograde Intrarenal Surgery, Device: Holmium laser devicePatients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones |
| third group | Active comparator | Procedure: Retrograde Intrarenal Surgery, Device: Holmium laser devicePatients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who have 2-3 cm kidney stones
- patients who are between 18-90 years old
Key exclusion criteria (2 listed)
- patients who have congenital urogenital abnormalities
- patients who have previous surgery history for urinary stones
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 |
|---|---|---|
| Retrograde Intrarenal SurgeryAlso: RIRSendoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device | Procedure or surgery | first group |
| Retrograde Intrarenal SurgeryAlso: RIRSRetrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) | Procedure or surgery | second group |
| Retrograde Intrarenal SurgeryAlso: RIRSRetrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) | Procedure or surgery | third group |
| Holmium laser device | Device | first group, second group, third group |
Primary outcome
Safety (Complications according to clavien system)
Time frame: 1 day
Complications according to clavien system
Efficiency (visual analog score)
Time frame: 1 Day
visual analog score
1 secondary outcome
Efficiency (stone free rate)
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Results publication: PubMed 25443519Redondo C, Ramon de Fata F, Gimbernat H, Meilan E, Andres G, Angulo JC. Retrograde intrarenal surgery with holmium-YAG laser lithotripsy in the primary treatment of renal lithiasis. Actas Urol Esp. 2015 Jun;39(5):320-6. doi: 10.1016/j.acuro.2014.06.004. Epub 2014 Oct 25. English, Spanish.
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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.
Nihat Karakoyunlu, MD principal investigator
Ministry of Health, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retrograde Intrarenal Surgery and Holmium laser device in people with Nephrolithiasis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 14 May 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nihat Karakoyunlu, MD (00905324747134, nkarakoyunlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Complications according to clavien system) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443909, which also lists 1 linked publication.
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 14 May 2015.