NCT05869890

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2024

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

May 12, 2023

Last Update Submit

February 19, 2025

Conditions

Renal Calculi

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Stone Free

    1 month after surgery

Study Arms (3)

Flexible Ureteroscopy with Dusting

OTHER

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

Flexible Ureteroscopy with Fragmentation

OTHER

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

Flexible Ureteroscopy with Hybrid

OTHER

Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.

Device: MOSES laser system

Interventions

MOSES laser systemDEVICE

A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,

Flexible Ureteroscopy with DustingFlexible Ureteroscopy with FragmentationFlexible Ureteroscopy with Hybrid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Manager for Luay Alshara

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 22, 2023

Study Start

February 22, 2023

Primary Completion

August 27, 2024

Study Completion

August 27, 2024

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations

US(1)