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

Not Applicable

Terminated

• Conditions: Stone Clearance
• Interventions: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

• Registration Number: NCT02683993
• Lead Sponsor: Boston Scientific Corporation

Brief 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

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 Timeline

• Study First Submitted: 2016-01-28
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stone breaking	Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber	Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Stone dusting	Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber	Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.

Primary Outcome Measures

Name	Time	Method
Stone Clearance	Stone clearance based on 1 month follow-up imaging data as compared to baseline	stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
hospital stay	Change from 1 month to baseline	hospital duration will be measured to evaluate treatment efficiency
Duration of catheterization time	Change from 1 month to baseline	Duration of catheterization will be measured to evaluate treatment efficiency
Procedure time	during the procedure	duration of the procedure as an indicator for treatment efficiency.
Usage of alternative stone extracting devices	as measured during the procedure	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.

Trial Locations

Locations (1)

New York Methodist Hospital; 🇺🇸 New York, New York, United States