NCT02683993

Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Detailed description

This is a randomized, two-arm, prospective, single center study. Subjects will undergo a single flexible ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study device, and will be treated as randomized to either stone breaking treatment or stone dusting treatment. Follow up visits are scheduled for the day of release from the hospital and at 1 month post procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part of the site standard of practice. Additional treatment sessions will not be included in this study.

Conditions

• Stone Clearance

Interventions

Type	Name	Description
DEVICE	Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber	The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-01-31
• Completion: 2017-01-31
• First posted: 2016-02-17
• Last updated: 2026-01-14
• Results posted: 2025-11-10

Locations

1 site across 1 country: United States