NCT02683993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

November 10, 2025

Completed
Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

January 28, 2016

Results QC Date

September 30, 2025

Last Update Submit

December 19, 2025

Conditions

Stone Clearance

Outcome Measures

Primary Outcomes (5)

  • 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

  • Post-procedure Catheterization

    Post-procedure catheterization by group

    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.

    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.

    as measured during the procedure

  • Hospital Stay

    Hospital duration was measured to evaluate treatment efficiency

    Procedure through hospital discharge

Secondary Outcomes (6)

  • Number of Participants With Intraoperative Complications

    Intraoperative

  • Visibility During Procedure

    Intraprocedural

  • Number of Participants With Occurrence of Retropulsion

    Intraoperative

  • Ability to Reach Stone Fragments

    Intraoperative

  • Damage to Scope or Fiber

    Intraoperative

  • +1 more secondary outcomes

Study Arms (2)

Stone breaking

EXPERIMENTAL

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

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.

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

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.

Stone breakingStone dusting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Methodist Hospital

New York, New York, 11215, United States

Location

Results Point of Contact

Title
Teri Bird
Organization
Boston Scientific
teri.bird@bsci.com
6123221189

Study Officials

  • Clayton Miller

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 17, 2016

Study Start

February 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

January 14, 2026

Results First Posted

November 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)