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CompletedNCT04069338CoLUMUpdated Dec 13, 2023

Comparison of Lithotripsy Urolithiasis Machines

An interventional study of Lithotripter in Kidney Stone, Kidney Calculi and Ureteral Calculi, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Kidney Stone
  • Kidney Calculi
  • Ureteral Calculi
  • Ureterolithiasis
  • Urolithiasis

Keywords

  • Lithotripsy
  • Extracorporeal shockwave lithotripsy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • Active comparator
    Device Storz Modulith SLX-F2

    Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2

    Procedure: Lithotripter

  • Active comparator
    Dornier Delta III Treatment

    Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter

    Procedure: Lithotripter

Interventions

  • ProcedureLithotripter

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

05

What researchers measure

Primary outcomes

  1. Stone free rate

    Presence of stone on follow up imaging

    Time frame: Four weeks post operative

Secondary outcomes

  1. Fluoroscopy time

    Length of fluoroscopy exposure

    Time frame: Intra-operative

  2. Treatment Time

    Length of surgical procedure

    Time frame: Intra-operative

  3. Pain Scores

    Response to visual analog scale

    Time frame: Four days post-operative

  4. Complication Rates

    Medical complications

    Time frame: One month post-operative

  5. Secondary Interventions required

    Follow up surgery

    Time frame: One month post-operative

06

Study locations

1 site
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04069338
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Aug 28, 2019
Start date
May 31, 2019
Primary completion
Oct 12, 2022
Completion
Oct 12, 2022
Last update
Dec 13, 2023

Study contacts

Manoj Monga, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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