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

Boston Scientific Corporation20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stone Clearance

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York Methodist Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Stone Clearance

stone clearance will be confirmed by CT or X-Ray at 1 month follow up.

Time frame: Stone clearance based on 1 month follow-up imaging data

Post-procedure Catheterization

Post-procedure catheterization by group

Time frame: 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.

Time frame: 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.

Time frame: as measured during the procedure

Hospital Stay

Hospital duration was measured to evaluate treatment efficiency

Time frame: Procedure through hospital discharge

Secondary Outcomes

Number of Participants With Intraoperative Complications

Number of participants with complications that occur during the procedure.

Time frame: Intraoperative

Visibility During Procedure

Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent

Time frame: Intraprocedural

Number of Participants With Occurrence of Retropulsion

Data from ClinicalTrials.gov

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