Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi

Not Applicable

Terminated

• Conditions: Renal Calculi

• Registration Number: NCT05869890
• Lead Sponsor: Albany Medical College

Brief Summary

This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.

Detailed Description

This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.

Study Timeline

• Study Start: 2023-02-22
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-22
• Primary Completion: 2024-08-27
• Study Completion: 2024-08-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Adults between the ages of 18-80.
• Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure.
• Must be suitable for a flexible ureteroscopy as determined by the MD
• Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm
• An average stone density of at least 1000 Hounsfield units.

Exclusion Criteria

• Those with a stone burden less than 10mm or more than 20mm.

• Those with an average stone density below 1000 Hounsfield units.

• Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery

• Patients that cannot undergo ureteral access sheath placement

• Patients with abnormal anatomy such as horseshoe kidney

• Patients with a history of:

  • Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi
  • Ipsilateral ureteral strictures
  • Prior radiotherapy of the abdomen or pelvis
  • Neurogenic bladder
  • Spinal cord injuries
  • Those who are pregnant
  • Currently being treated for infection or cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduced OR time	2 hours	Hybrid technique will result in overall reduced OR time
Less Energy Transmission to Patient	2 hours	Hybrid technique will have less energy transmission to the patient

Secondary Outcome Measures

Name	Time	Method
Stone Free	1 month after surgery

Trial Locations

Locations (1)

Albany Medical College; 🇺🇸 Albany, New York, United States