The Comparison of the Efficacy and Safety of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Randomized Controlled Prospective Multicenter Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Patients over 18 years of age
• Patients below 85 years of age
• Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery
Locations
Other Locations
Turkey
Tekirdag Namık Kemal University
RECRUITING
Tekirdağ
Contact Information
Primary
Mehmet F. Şahin, Ass. Professor
mfatihsahin@gmail.com
+905555511871
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 150
Treatments
Active_comparator: Patients with conventional UAS being used in their RIRS operations
The patient population will be selected from cases determined by randomization and used with UAS without an aspiration (conventional) during RIRS.
Experimental: Patients with vacuum assisted UAS being used in their RIRS operations
The patient population will be selected from cases determined by randomization and used with UAS with an aspiration and flexible tip, different from the conventional one during RIRS.
Related Therapeutic Areas
Sponsors
Leads: Namik Kemal University