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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Calculi
• Intervention / Treatment: Device: MOSES laser system

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Davey; Phone Number: 518-262-8579; Email: AMCUrologyresearch@amc.edu
• Study Contact Backup: Name: Brenda Romeo; Phone Number: 518-262-3349; Email: AMCUrologyresearch@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical College
      • Contact: Laura Davey; Phone Number: 518-262-8579; Email: AMCUrologyresearch@amc.edu
      • Contact: Brenda Romeo; Phone Number: 518-262-3349; Email: AMCUrologyresearch@amc.edu
      • Principal Investigator: Luay Alshara, MD
      • Sub-Investigator: Mark White, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Flexible Ureteroscopy with Dusting; 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	Device: MOSES laser system; A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,
Other: Flexible Ureteroscopy with Fragmentation; Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz	Device: MOSES laser system; A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,
Other: Flexible Ureteroscopy with Hybrid; Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.	Device: MOSES laser system; A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Stone Free	1 month after surgery

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 6286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes