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

Stone Clearance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02683993
• Other study ID #: LUM-SBU-VP-15-01
• Status: Active, not recruiting
• Phase: N/A
• First received: January 28, 2016
• Last updated: August 28, 2017
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Stone Clearance

Intervention

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.

Locations

Country	Name	City	State
United States	New York Methodist Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration of catheterization time	Duration of catheterization will be measured to evaluate treatment efficiency	Change from 1 month to baseline
Primary	Procedure time	duration of the procedure as an indicator for treatment efficiency.	during the procedure
Primary	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
Primary	hospital stay	hospital duration will be measured to evaluate treatment efficiency	Change from 1 month to baseline
Secondary	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
Secondary	Visibility during procedure	clear vision of the stone and organ compartments as reflected via endoscope and video screen.	during the procedure
Secondary	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
Secondary	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