NCT00952315

Brief Summary

The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

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

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

June 1, 2019

Enrollment Period

7.2 years

First QC Date

August 3, 2009

Results QC Date

March 5, 2019

Last Update Submit

June 27, 2019

Conditions

Kidney Stones

Keywords

kidney stonesintracorporeal lithotriptorskidney stone removal

Outcome Measures

Primary Outcomes (1)

  • Stone Clearance Time in mm2/Min

    Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)

    collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket

Secondary Outcomes (9)

  • Stone-free After First Procedure

    Post-operative Day 1

  • Secondary Procedure Required

    Within three days of initial procedure

  • Ureteral Stent Placed

    Intra-operatively

  • Nephrostomy Tube Placed

    Intra-operatively

  • Use of Other Device

    Intra-operatively

  • +4 more secondary outcomes

Study Arms (3)

Stonebreaker

ACTIVE COMPARATOR

Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.

Device: Stonebreaker

Lithoclast Select

ACTIVE COMPARATOR

Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.

Device: Lithoclast Select

Cyberwand

ACTIVE COMPARATOR

The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.

Device: Cyberwand

Interventions

CyberwandDEVICE

Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.

Cyberwand
StonebreakerDEVICE

Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.

Stonebreaker
Lithoclast SelectDEVICE

Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented

Lithoclast Select

Eligibility Criteria

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

You may qualify if:

  • Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
  • Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
  • Age 18 years or older
  • Able to give informed consent

You may not qualify if:

  • Size of single largest stone less than 2 cm
  • Pregnancy
  • Active urinary tract infection
  • Extracorporeal shockwave lithotripsy within the last three months
  • Complex stone anticipating multiple access sites
  • Stones that are not clearly able to be measured on KUB or CT scan
  • Inability to give informed consent
  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mayo Clinic Scottsdale

Phoenix, Arizona, 85054, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

IU Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

The University of Western Ontario

London, Ontario, N6A 4V2, Canada

Location

Related Links

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
James Lingeman, MD
Organization
IU Health Physicians Urology
317-962-3700

Study Officials

  • James E Lingeman, MD

    IU Health Physicians Urology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
James Lingeman, MD

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(8)CA(2)