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Completed

NCT Number: NCT04069338

Comparison of Lithotripsy Urolithiasis Machines

A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.

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Key information

About this study

This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed
  • Age ≥ 18 years old
  • Male and female patients
  • Patients of all ethnic backgrounds
  • Stone size 5-15mm
  • Stone location: Renal or proximal ureter
  • Stone density: < 1200 Hounsfield Units
  • Skin to stone distance: < 12cm
  • Primary treatment for a solitary stone (must be previously untreated)

Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

Exclusion criteria

  • Prior treatment for specified stone
  • Multiple stones on treatment side (even if only one is treated)
  • Anticoagulated or history of coagulopathy
  • Prior ureteral stent placement
  • Technical problems/impossibility of localizing the stone on the day of intervention

Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Treatment and study plan

Lithotripter

Procedure

Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines

Primary outcomes

  1. Stone free rate

    Time frame: Four weeks post operative

    Presence of stone on follow up imaging

Secondary outcomes

  1. Fluoroscopy time

    Time frame: Intra-operative

    Length of fluoroscopy exposure

  2. Treatment Time

    Time frame: Intra-operative

    Length of surgical procedure

  3. Pain Scores

    Time frame: Four days post-operative

    Response to visual analog scale

  4. Complication Rates

    Time frame: One month post-operative

    Medical complications

  5. Secondary Interventions required

    Time frame: One month post-operative

    Follow up surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines

Acronym: CoLUM

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Dec 13, 2023

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.

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