NCT00351351

Brief Summary

Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. Currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
2 countries

7 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

July 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

February 20, 2013

Completed
Last Updated

March 30, 2017

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

July 11, 2006

Results QC Date

December 4, 2012

Last Update Submit

March 1, 2017

Conditions

Kidney Stones

Keywords

Kidney StonesRenal Calculi

Outcome Measures

Primary Outcomes (1)

  • Kidney Stone Clearance Rate

    stone clearance rate calculated in mm\^2/min per protocol specification

    6 months

Study Arms (2)

A

EXPERIMENTAL

Cyberwand

Device: Cyberwand

B

ACTIVE COMPARATOR

Currently available lithotripsy technology

Device: single probe ultrasonic

Interventions

CyberwandDEVICE

FDA approved - dual probe intracorporeal lithotrite

A
single probe ultrasonicDEVICE

FDA-approved - single probe ultrasonic

B

Eligibility Criteria

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

You may qualify if:

  • Patient of Methodist Urology in Indianapolis, IN
  • Undergoing percutaneous nephrolithotomy for calculi greater than 2 cm
  • Age 18 years or older
  • Stone easily visible/measurable on kidney, ureters and bladder (KUB) or computed tomography (CT) scan preoperatively

You may not qualify if:

  • Radiolucent stones
  • Size of largest stone less than 2 cm
  • Pregnancy
  • Inability to give informed consent
  • Multiple percutaneous access anticipated
  • Active urinary tract infection
  • Recent (within last 3 months) extracorporeal shock wave lithotripsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Northwestern University Dept. of Urology

Chicago, Illinois, 60611, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

John's Hopkins University

Baltimore, Maryland, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Vancouver Hospital

Vancouver, British Columbia, Canada

Location

University of Western Ontario - St. Joseph's Hospital

London, Ontario, Canada

Location

Related Publications (1)

  • Kuo RL, Paterson RF, Siqueira TM Jr, Evan AP, McAteer JA, Williams JC Jr, Lingeman JE. In vitro assessment of lithoclast ultra intracorporeal lithotripter. J Endourol. 2004 Mar;18(2):153-6. doi: 10.1089/089277904322959789.

    PMID: 15072622BACKGROUND

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

Limitations and Caveats

Multiple surgeons were involved,thus subtle differences in PCNL technique existed between sites. Some surgeons may have defined the stone removal time differently.

Results Point of Contact

Title
James Lingeman, MD
Organization
IU Health Methodist Hospital
lrawlings@iuhealth.org
317-962-0870

Study Officials

  • James E. Lingeman, MD

    Methodist Urology

    PRINCIPAL INVESTIGATOR

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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 30, 2017

Results First Posted

February 20, 2013

Record last verified: 2013-02

Locations

US(5)CA(2)