Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
1 other identifier
interventional
90
1 country
1
Brief Summary
To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMay 21, 2015
May 1, 2015
1.9 years
April 28, 2015
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety - complications according to clavien system
complications according to clavien system
postoperative 24 hours
safety - visual analog score
visual analog score
postoperative 24 hours
Secondary Outcomes (1)
efficiency - stone free rate
postoperative 24 hours
Study Arms (3)
first group
ACTIVE COMPARATORPatients undergoing Retrograde Intrarenal Surgery with 20w holmium laser device who have 1-2 cm diameter kidney stones
second group
ACTIVE COMPARATORPatients undergoing Retrograde Intrarenal Surgery with 30w holmium laser device (working over 20w power) who have 1-2 cm diameter kidney stones
third group
ACTIVE COMPARATORPatients undergoing Retrograde Intrarenal Surgery with 30w holmium laser(working under 20w power) device who have 1-2 cm diameter kidney stones
Interventions
Endoscopic treatment of Kidney Stones
Eligibility Criteria
You may qualify if:
- Patients who are between 18-90 years old
- Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones
You may not qualify if:
- Patients who have congenital urogenital abnormalities
- Patients who have previous stone surgery history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tuekey Ministry of HealthDıskapı Yıldırım Beyazıt Training and Research Hospital
Ankara, 06110, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 25443519RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nihat Karakoyunlu, MD
Dıskapı TRH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 21, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
May 21, 2015
Record last verified: 2015-05