deltatrials
Completed NA INTERVENTIONAL 2-arm NCT00351351

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

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

Sponsor: Indiana Kidney Stone Institute

Conditions Kidney Stones
Updated 7 times since 2017 Last updated: Mar 1, 2017 Started: Jul 31, 2006 Primary completion: May 31, 2008 Completion: May 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Kidney Stones and is currently completed. Indiana Kidney Stone Institute leads this study, which shows 7 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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....

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Dec 2021 — Jul 2024 [monthly]

    Completed NA

  5. Jan 2021 — Dec 2021 [monthly]

    Completed NA

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  2. Jan 2017 — Jun 2018 [monthly]

    Completed NA

    First recorded

Jul 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Indiana Kidney Stone Institute
Data source: Indiana Kidney Stone Institute

For direct contact, visit the study record on ClinicalTrials.gov .