Stone ClearanceNCT02683993

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

A study testing Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber in people with Stone Clearance, run by Boston Scientific Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stone Clearance
What is being tested?: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2016to 31 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject will be older than 18 years of age
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.
Subject is a candidate for FURS procedure
Subject is willing and has signed the Informed Consent Form

Who cannot join

Subject has undergone a previous treatment for stones in the same kidney
Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
Female subject is pregnant
Concomitant anticoagulant medication that cannot be suspended during surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Methodist Hospital
New York, New York, 11215

Other trials in United States

About this study

Read the detailed description

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: Stone Clearance
Being tested: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02683993
Study group	Role	What they receive
Stone breaking	Experimental	Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters. Receives: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
Stone dusting	Experimental	Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters. Receives: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

What is being measured

The primary outcome is the main question the study is designed to answer.

Stone Clearance
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Measured: Stone clearance based on 1 month follow-up imaging data
Post-procedure Catheterization
Post-procedure catheterization by group
Measured: 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.
Measured: 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.
Measured: as measured during the procedure
Hospital Stay
Hospital duration was measured to evaluate treatment efficiency
Measured: Procedure through hospital discharge

Secondary outcomes (6)

Number of Participants With Intraoperative Complications
Number of participants with complications that occur during the procedure.
Measured: Intraoperative
Visibility During Procedure
Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent
Measured: Intraprocedural
Number of Participants With Occurrence of Retropulsion
Occurrence of retropulsion by group
Measured: Intraoperative
Ability to Reach Stone Fragments
Performance rating of ability to reach stone fragments by group
Measured: Intraoperative
Damage to Scope or Fiber
Damage to scope or fiber by group
Measured: Intraoperative
Fiber Transmission
Fiber transmission (preserving energy transmission during lasing) by group
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201631 Jan 2017

First posted17 Feb 2016 (estimated)
Study startFeb 2016
Primary completion31 Jan 2017
Study completion31 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stone ClearanceStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02683993
Sponsor's protocol ID: LUM-SBU-VP-15-01
Status last verified: Dec 2025
First submitted: 28 Jan 2016
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Recruiting
Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath
Stone;Renal, Stone, Urinary
Recruiting
Early vs Late Laparoscopic Cholecystectomy After Common Bile Duct Stones Clearance Through Ercp.
Laparoscopic Cholecystectomy, Choledocholithiasis
Recruiting
INtraoperative Approach With Eventual Clearance of Common bilE Duct by SpyGlass Discover vs Sequential Strategy in Patients With Acute Calculus Cholecystitis and Intermediate/High Risk of Common BiLE Duct Stone
Acute Calculous Cholecystitiis (ACC)

All Stone Clearance trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
ClinicalTrials.gov ID: NCT02683993
Acronym / sponsor ID: LUM-SBU-VP-15-01
Conditions: Stone Clearance
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Collaborators: Lumenis Be Ltd.
Study start: Feb 2016 (actual)
Primary completion: 31 Jan 2017 (actual)
Study completion: 31 Jan 2017 (actual)
First posted: 17 Feb 2016 (estimated)
Results: Posted 10 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stone breaking	Experimental	Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiberLithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Stone dusting	Experimental	Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiberLithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject will be older than 18 years of age
Subject was diagnosed with renal calculi meeting the following criteria:
Subject is a candidate for FURS procedure
Subject is willing and has signed the Informed Consent Form

Key exclusion criteria (4 listed)

Subject has undergone a previous treatment for stones in the same kidney
Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
Female subject is pregnant
Concomitant anticoagulant medication that cannot be suspended during surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiberThe Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.	Device	Stone breaking, Stone dusting

Primary outcome

Stone Clearance
Time frame: Stone clearance based on 1 month follow-up imaging data
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Post-procedure Catheterization
Time frame: Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure
Post-procedure catheterization by group
Procedure Time
Time frame: during the procedure
Duration (in minutes) of the procedure as an indicator for treatment efficiency.
Usage of Alternative Stone Extracting Devices
Time frame: 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.
Hospital Stay
Time frame: Procedure through hospital discharge
Hospital duration was measured to evaluate treatment efficiency

6 secondary outcomes

Number of Participants With Intraoperative Complications
Time frame: Intraoperative
Visibility During Procedure
Time frame: Intraprocedural
Number of Participants With Occurrence of Retropulsion
Time frame: Intraoperative
Ability to Reach Stone Fragments
Time frame: Intraoperative
Damage to Scope or Fiber
Time frame: Intraoperative
Fiber Transmission
Time frame: Intraoperative

Results and safety

Results posted to the registry on 10 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stone Breaking	10	10
Stone Dusting	10	10

Primary outcome: Stone Clearance

Time frame: Stone clearance based on 1 month follow-up imaging data. Count of participants. Unit: Participants

Measure	Stone Breaking n = 10	Stone Dusting n = 10
Complete clearance	6	6
Evidence of fragments not requiring intervention	3	4
Evidence of fragments requiring an additional intervention	1	0

Primary outcome: Post-procedure Catheterization

Time frame: Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure. Count of participants. Unit: Participants

Measure	Stone Breaking n = 10	Stone Dusting n = 10
Ureteric catheter not placed at the end of procedure	9	9
Ureteric catheter placed at the end of procedure and not removed at hospital discharge	1	0
Ureteric catheter placed at the end of procedure; removal at hospital discharge unknown	0	1

Primary outcome: Procedure Time

Time frame: during the procedure. Mean (Standard Deviation). Unit: Minutes

Measure	Stone Breaking n = 10	Stone Dusting n = 10
Value	46.3 (24.8)	36.1 (16.5)

Primary outcome: Usage of Alternative Stone Extracting Devices

Time frame: as measured during the procedure. Count of participants. Unit: Participants

Measure	Stone Breaking n = 10	Stone Dusting n = 10
Any alternate stone extracting devices used	0	1
No alternate stone extracting devices used	10	9

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Intra-operative to 1 month post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stone Breaking	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Stone Dusting	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stone Clearance

RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Recruiting
Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath
Stone;Renal, Stone, Urinary
Recruiting
Early vs Late Laparoscopic Cholecystectomy After Common Bile Duct Stones Clearance Through Ercp.
Laparoscopic Cholecystectomy, Choledocholithiasis
Recruiting
INtraoperative Approach With Eventual Clearance of Common bilE Duct by SpyGlass Discover vs Sequential Strategy in Patients With Acute Calculus Cholecystitis and Intermediate/High Risk of Common BiLE Duct Stone
Acute Calculous Cholecystitiis (ACC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clayton Miller study director

Boston Scientific Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber in people with Stone Clearance, run by Boston Scientific Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone Clearance (time frame: Stone clearance based on 1 month follow-up imaging data). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02683993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.