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

• Study Type: Interventional
• Enrollment (Anticipated): 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
• Genders Eligible for Study: All

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 as compared to baseline
Duration of catheterization time	Duration of catheterization will be measured to evaluate treatment efficiency	Change from 1 month to baseline
Procedure time	duration 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 will be measured to evaluate treatment efficiency	Change from 1 month to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Complications	Intraoperative Complications will be evaluated based on Modified Clavien Classification- Modified Clavien Grading: Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5.	during the procedure and during 1 month follow up
Visibility during procedure	clear vision of the stone and organ compartments as reflected via endoscope and video screen.	during the procedure
Occurrence of retropulsion that interferes with procedure	The subjective degree of stone movement and migration as a result of the laser treatment that interfere with procedure flow.	during the procedure
Fiber performance	The surgeon will evaluate the degree of Fiber flexibility with scope deflection- and any damage to fiber, Fiber durability- deflection without losing energy/ efficiency and any Damage to scope.	during the procedure

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: LUM-SBU-VP-15-01