Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02451319
Other study ID # 26.01.2015 19/17
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04746378 - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT03692715 - Antibiotic Prophylaxis Before Shock Wave Lithotripsy Phase 4
Completed NCT02547805 - Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days Phase 2
Completed NCT02289755 - Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria Phase 2
Completed NCT01690039 - Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis
Completed NCT01650935 - Comparison of DASH With Oxalate Restricted Diet on Urine in Recurrent Stone Formers With Hyperoxaluria N/A
Completed NCT01295879 - Vitamin D Repletion in Stone Formers With Hypercalciuria Phase 4
Recruiting NCT05014178 - Kidney Sodium Functional Imaging
Not yet recruiting NCT06199102 - The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. N/A
Recruiting NCT04374188 - Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy N/A
Recruiting NCT04367155 - Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Recruiting NCT04389853 - Mini-PNCL vs fURS in Management of Nephrolithiasis N/A
Completed NCT03348228 - Effect of Hydroxycitrate on Urine Chemistry N/A
Completed NCT05350423 - Trial Assessing Renal Damage During Ureteroscopy N/A
Completed NCT03454139 - Subcostal TAP Block For Percutaneous Nephrolithotomy N/A
Recruiting NCT02279927 - Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy N/A
Completed NCT02276924 - Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors N/A
Completed NCT00159393 - Percutaneous Nephrolithotomy: A Registry and Database