Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.

In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.

We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.

Conditions

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Stonebreaker

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

Group Type ACTIVE_COMPARATOR

Stonebreaker

Intervention Type DEVICE

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

Lithoclast Select

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

Group Type ACTIVE_COMPARATOR

Lithoclast Select

Intervention Type DEVICE

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

Cyberwand

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

Group Type ACTIVE_COMPARATOR

Cyberwand

Intervention Type DEVICE

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

Interventions

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Cyberwand

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

Intervention Type DEVICE

Stonebreaker

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

Intervention Type DEVICE

Lithoclast Select

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No