Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS

Nephrolithiasis Clinical Trial

Official title:

Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02451319
• Other study ID #: 26.01.2015 19/17
• Status: Recruiting
• Phase: Phase 4
• First received: April 28, 2015
• Last updated: May 20, 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 the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 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 are between 18-90 years old

• Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones

Exclusion Criteria:

• Patients who have congenital urogenital abnormalities

• Patients who have previous stone surgery history

Study Design

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

Related Conditions & MeSH terms

• Nephrolithiasis

Intervention

Procedure:
• Retrograde Intrarenal Surgery
Endoscopic treatment of Kidney Stones

Locations

Country	Name	City	State
Turkey	Tuekey Ministry of HealthDiskapi 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	postoperative 24 hours	Yes
Primary	safety - visual analog score	visual analog score	postoperative 24 hours	Yes
Secondary	efficiency - stone free rate	stone free rate post operative first day	postoperative 24 hours	Yes