Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy

NCT ID: NCT00351351

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-05-31

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.

Detailed Description

Percutaneous nephrolithotomy (PNL) is used to remove large and complex stones from the upper urinary tract. Intracorporeal lithotripsy is an integral part of PNL. Commercially available intracorporeal lithotripsy modalities include ultrasonic, pneumatic, and combined ultrasonic and pneumatic models. Each modality has its inherent advantages and disadvantages. Ultrasonic lithotrites are capable of fragmenting stones while concomitantly suctioning out fragments. Unfortunately some stones are hard enough to resist fragmentation from ultrasonic lithotripsy. Pneumatic lithotrites are able to fragment all stones regardless of hardness, but this modality is unable to suction out stone pieces at the same time fragmentation is occurring. The newest lithotrite which combines both ultrasonic and pneumatic components is capable of fragmenting any stone, but also has some inherent limitations. The handpiece of the lithotripsy device is somewhat cumbersome, the suction component can clog, and the device has overheated at the maximal settings (Kuo et al). Current intracorporeal lithotrites, while functional, can certainly be improved.

Recently, a novel dual probe design has been introduced by Cybersonics of Erie, PA. 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 revolutionalize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Conditions

Kidney Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Cyberwand

Group Type: EXPERIMENTAL

Cyberwand

Intervention Type: DEVICE

FDA approved - dual probe intracorporeal lithotrite

B

Currently available lithotripsy technology

Group Type: ACTIVE_COMPARATOR

single probe ultrasonic

Intervention Type: DEVICE

FDA-approved - single probe ultrasonic

Interventions

Cyberwand

FDA approved - dual probe intracorporeal lithotrite

Intervention Type: DEVICE

single probe ultrasonic

FDA-approved - single probe ultrasonic

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana Kidney Stone Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James E. Lingeman, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Urology

Locations

Northwestern University Dept. of Urology

Chicago, Illinois, United States

Methodist Hospital

Indianapolis, Indiana, United States

John's Hopkins University

Baltimore, Maryland, United States

Duke University

Durham, North Carolina, United States

University of Wisconsin

Madison, Wisconsin, United States

Vancouver Hospital

Vancouver, British Columbia, Canada

University of Western Ontario - St. Joseph's Hospital

London, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 15072622 (View on PubMed)

Other Identifiers

06-035

Identifier Type: -

Identifier Source: org_study_id