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

Renal Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869890
• Other study ID #: 6286
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2023
• Source: Albany Medical College
• Contact: Laura Davey
• Phone: 518-262-8579
• Email: AMCUrologyresearch[@]amc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi

Intervention

Device:
• MOSES laser system
A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced OR time	Hybrid technique will result in overall reduced OR time	2 hours
Primary	Less Energy Transmission to Patient	Hybrid technique will have less energy transmission to the patient	2 hours
Secondary	Stone Free		1 month after surgery