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

NCT ID: NCT02683993

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-31

Brief Summary

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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

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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

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Stone Clearance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stone breaking

Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.

Group Type EXPERIMENTAL

Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

Intervention Type DEVICE

The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.

Stone dusting

Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.

Group Type EXPERIMENTAL

Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

Intervention Type DEVICE

The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lumenis Be Ltd.

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New York Methodist Hospital

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LUM-SBU-VP-15-01

Identifier Type: -

Identifier Source: org_study_id