MOSES Lithotripsy Technology Applied to Stone Fragmentation During Ureteroscopy

NCT03995758 | Terminated Results DMC FDA Device

• 1 other identifier: 1901990102
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the effects of MOSES laser modulation technology can improve the safety and efficiency to laser fragmentation resulting in decreased total laser time, reduced potential for injury to the patient, and total OR time and utilization.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of Interest Will be Reduction in Mean Total OR Time

  To determine the effects of MOSES laser modulation technology can improve the safety and efficiency to laser fragmentation resulting in decreased total laser time, reduced potential for injury to the patient, and total OR time and utilization.

  Postoperative day 1

Secondary Outcomes (1)

• Number of Participants With Complications

  30 days

Study Arms (2)

Standard laser lithotripsy

ACTIVE COMPARATOR

standard of care for stone fragmentation in ureteroscopy

Device: MOSES

MOSES laser lithotripsy

ACTIVE COMPARATOR

MOSES technology used for stone fragmentation in ureteroscopy

Device: MOSES

Interventions

MOSES DEVICE

software based modulation of the laser energy delivered from the homium laser source. The software changes the pulsed laser to have two peaks of energy - one to displace water in front of the stone and a second to deliver the laser energy to the stone

MOSES laser lithotripsy; Standard laser lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Kidney or ureteral stone requiring laser lithotripsy fragmentation

You may not qualify if:

• \< 18 years of age
• Infectious, struvite stones.
• Atypical collecting system anatomy that prolongs the case (ureteral stricture, malrotated kidney, infundibular stenosis, ureteral duplication)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Marcelino Rivera
• Organization: Indiana University School of Medicine

maeriver@iu.edu

3179622485

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Surgeons will not be aware of the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients will be randomized 1:1 to either standard laser lithotripsy or MOSES laser lithotripsy.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: June 6, 2019
• Primary Completion: May 13, 2021
• Study Completion: June 11, 2021
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)