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NCT02443909 Clinical Trial

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

Nephrolithiasis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02443909
Other study ID # 26.01.2015
Secondary ID
Status Recruiting
Phase Phase 4
First received April 28, 2015
Last updated May 13, 2015
Start date January 2015
Est. completion date January 2017

Study information
Verified date May 2015
Source Diskapi Teaching and Research Hospital
Contact Nihat Karakoyunlu, MD
Phone 00905324747134
Email nkarakoyunlu@gmail.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- patients who have 2-3 cm kidney stones

- patients who are between 18-90 years old

Exclusion Criteria:

- patients who have congenital urogenital abnormalities

- patients who have previous surgery history for urinary stones

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Retrograde Intrarenal Surgery
endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
• Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
• Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Device:
• Holmium laser device

Locations
Country Name City State
Turkey S.B.Diskapi Yildirim Beyazit Training and Research Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Redondo C, Ramón de Fata F, Gimbernat H, Meilán E, Andrés 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. E — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (Complications according to clavien system) Complications according to clavien system 1 day Yes
Primary Efficiency (visual analog score) visual analog score 1 Day Yes
Secondary Efficiency (stone free rate) stone free rate/ 3 month No
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