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

Not Applicable

Terminated

• Conditions: Renal Calculi
• Interventions: Device: MOSES laser system

• 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

Arm && Interventions

Group	Intervention	Description
Flexible Ureteroscopy with Dusting	MOSES laser system	Flexible ureteroscopy with the dusting lasing technique. MOSES parameters will be set to an energy of 0.3-0.4 Jules and a frequency of 50-80 hertz
Flexible Ureteroscopy with Hybrid	MOSES laser system	Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.
Flexible Ureteroscopy with Fragmentation	MOSES laser system	Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz

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