Skip to main content
OpenTrials
Completed

NCT Number: NCT00952315

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyberwand

Device

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

Stonebreaker

Device

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

Lithoclast Select

Device

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

Primary outcomes

  1. Stone Clearance Time in mm2/Min

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

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

Secondary outcomes

  1. Stone-free After First Procedure

    Time frame: Post-operative Day 1

    Number of participants deemed stone-free after initial stone-removal surgery

  2. Secondary Procedure Required

    Time frame: Within three days of initial procedure

    Number of participants who required a secondary kidney stone removal procedure

  3. Ureteral Stent Placed

    Time frame: Intra-operatively

    Participants requiring a ureteral stent to be placed after initial stone removal procedure

  4. Nephrostomy Tube Placed

    Time frame: Intra-operatively

    Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure

  5. Use of Other Device

    Time frame: Intra-operatively

    Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite

  6. EBL>400mL

    Time frame: Intra-operatively

    Number of participants with an estimated blood loss greater than 400mL

  7. RBC Transfusion

    Time frame: Post-operatively <24 hours

    Number of participants who required a blood transfusion post-operatively

  8. Length of Stay

    Time frame: Post-operatively

    Number of days participants were in hospital. Operative day is Day 1.

  9. Post-operative Complications

    Time frame: Post-operative Days 2 and 3

    Number of participants who experienced surgery-related post-op complications

Sponsors and collaborators

Lead sponsor

Indiana Kidney Stone Institute

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
Aug 6, 2009
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.