Trial Outcomes & Findings for MOSES Lithotripsy Technology Applied to Stone Fragmentation During Ureteroscopy (NCT NCT03995758)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

Postoperative day 1

Results posted on

2025-07-04

Participant Flow

The recruitment period for this study started in June 2019 and concluded in March 2021. Patients for the study were recruited in clinic.

There are no significant events that occurred after participant enrollment.

Participant milestones

Participant milestones
Measure	Standard Laser Lithotripsy Standard of care for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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 MOSES technology used for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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
Overall Study STARTED	58	58
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Laser Lithotripsy n=32 Participants standard of care for stone fragmentation in ureteroscopy MOSES: 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 n=31 Participants MOSES technology used for stone fragmentation in ureteroscopy MOSES: 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	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=32 Participants	0 Participants n=31 Participants	0 Participants n=63 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants	31 Participants n=31 Participants	63 Participants n=63 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants	0 Participants n=31 Participants	0 Participants n=63 Participants
Sex: Female, Male Female	17 Participants n=32 Participants	15 Participants n=31 Participants	32 Participants n=63 Participants
Sex: Female, Male Male	15 Participants n=32 Participants	16 Participants n=31 Participants	31 Participants n=63 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Postoperative day 1

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.

Outcome measures

Outcome measures
Measure	Standard Laser Lithotripsy n=32 Participants Standard of care for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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 n=31 Participants MOSES technology used for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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
The Primary Endpoint of Interest Will be Reduction in Mean Total OR Time	68.2 Minutes Standard Deviation 35.0	64.2 Minutes Standard Deviation 33.4

SECONDARY outcome

Timeframe: 30 days

Clavien Classification of Surgical Complications: Grade I: Any deviation from the normal post-operative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for Grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication (including CNS complications) requiring IC/ICU management. Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multi-organ dysfunction Grade V: Death of a patient

Outcome measures

Outcome measures
Measure	Standard Laser Lithotripsy n=32 Participants Standard of care for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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 n=31 Participants MOSES technology used for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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
Number of Participants With Complications	0 Participants	1 Participants

POST_HOC outcome

Timeframe: Postoperative day 1

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.

Outcome measures

Outcome measures
Measure	Standard Laser Lithotripsy n=32 Participants Standard of care for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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 n=31 Participants MOSES technology used for stone fragmentation in ureteroscopy MOSES: software based modulation of the laser energy delivered from the holmium 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
The Primary Endpoint of Interest Will be Reduction in Mean Total Laser Time	77.6 Seconds Standard Deviation 68.3	84.5 Seconds Standard Deviation 107.3

Adverse Events

Standard Laser Lithotripsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MOSES Laser Lithotripsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marcelino Rivera

Indiana University School of Medicine

Phone: 3179622485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place