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

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.

Study Overview

• Status: Completed
• Conditions: Stone Clearance
• Intervention / Treatment: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • New York Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject will be older than 18 years of age

2. Subject was diagnosed with renal calculi meeting the following criteria:

   • Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
   • Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
3. Subject is a candidate for FURS procedure
4. Subject is willing and has signed the Informed Consent Form

Exclusion Criteria:

1. Subject has undergone a previous treatment for stones in the same kidney
2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
3. Female subject is pregnant
4. Concomitant anticoagulant medication that cannot be suspended during surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stone breaking; Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.	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.
Experimental: Stone dusting; Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone Clearance	stone clearance will be confirmed by CT or X-Ray at 1 month follow up.	Stone clearance based on 1 month follow-up imaging data
Post-procedure Catheterization	Post-procedure catheterization by group	Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure
Procedure Time	Duration (in minutes) of the procedure as an indicator for treatment efficiency.	during the procedure
Usage of Alternative Stone Extracting Devices	The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.	as measured during the procedure
Hospital Stay	Hospital duration was measured to evaluate treatment efficiency	Procedure through hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Intraoperative Complications	Number of participants with complications that occur during the procedure.	Intraoperative
Visibility During Procedure	Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent	Intraprocedural
Number of Participants With Occurrence of Retropulsion	Occurrence of retropulsion by group	Intraoperative
Ability to Reach Stone Fragments	Performance rating of ability to reach stone fragments by group	Intraoperative
Damage to Scope or Fiber	Damage to scope or fiber by group	Intraoperative
Fiber Transmission	Fiber transmission (preserving energy transmission during lasing) by group	Intraoperative

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Lumenis Be Ltd.
• Investigators: Study Director: Clayton Miller, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimated): February 17, 2016

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

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: LUM-SBU-VP-15-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO