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Comparison of Lithotripsy Urolithiasis Machines (CoLUM)

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ClinicalTrials.gov Identifier: NCT04069338
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Kidney Stone Kidney Calculi Ureteral Calculi Ureterolithiasis Urolithiasis Procedure: Lithotripter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


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

Active Comparator: Dornier Delta III Treatment
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Procedure: Lithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines




Primary Outcome Measures :
  1. Stone free rate [ Time Frame: 4 weeks post operative ]
    Presence of stone on follow up imaging


Secondary Outcome Measures :
  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: 2 days post-operative ]
    Response to visual analog scale

  4. Complication Rates [ Time Frame: 1 month post-operative ]
    Medical complications

  5. Secondary Interventions required [ Time Frame: 1 month post-operative ]
    Follow up surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069338


Contacts
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Contact: Manoj Monga, MD 216 445-8678 mongam@ccf.org
Contact: Naveen Kachroo, MD 216-973-5227 kachron@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Manoj Monga, MD    216-445-8678    mongam@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Manoj Monga, MD The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04069338     History of Changes
Other Study ID Numbers: 19-619
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Lithotripsy
Extracorporeal shockwave lithotripsy
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Urolithiasis
Ureteral Calculi
Ureterolithiasis
Calculi
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Ureteral Diseases