Back to resultsComparison of Lithotripsy Urolithiasis Machines (CoLUM)
Primary Purpose
Kidney Stone, Kidney Calculi, Ureteral Calculi
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lithotripter
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring Lithotripsy, Extracorporeal shockwave lithotripsy
Eligibility 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.
Sites / Locations
- Cleveland Clinic FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Device Storz Modulith SLX-F2
Dornier Delta III Treatment
Arm Description
Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Outcomes
Primary Outcome Measures
Stone free rate
Presence of stone on follow up imaging
Secondary Outcome Measures
Fluoroscopy time
Length of fluoroscopy exposure
Treatment Time
Length of surgical procedure
Pain Scores
Response to visual analog scale
Complication Rates
Medical complications
Secondary Interventions required
Follow up surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04069338
Brief Title
Comparison of Lithotripsy Urolithiasis Machines
Acronym
CoLUM
Official Title
Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Kidney Calculi, Ureteral Calculi, Ureterolithiasis, Urolithiasis
Keywords
Lithotripsy, Extracorporeal shockwave lithotripsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device Storz Modulith SLX-F2
Arm Type
Active Comparator
Arm Description
Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2
Arm Title
Dornier Delta III Treatment
Arm Type
Active Comparator
Arm Description
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Intervention Type
Procedure
Intervention Name(s)
Lithotripter
Intervention Description
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Primary Outcome Measure Information:
Title
Stone free rate
Description
Presence of stone on follow up imaging
Time Frame
Four weeks post operative
Secondary Outcome Measure Information:
Title
Fluoroscopy time
Description
Length of fluoroscopy exposure
Time Frame
Intra-operative
Title
Treatment Time
Description
Length of surgical procedure
Time Frame
Intra-operative
Title
Pain Scores
Description
Response to visual analog scale
Time Frame
Four days post-operative
Title
Complication Rates
Description
Medical complications
Time Frame
One month post-operative
Title
Secondary Interventions required
Description
Follow up surgery
Time Frame
One month post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manoj Monga, MD
Phone
216 445-8678
Email
mongam@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Naveen Kachroo, MD
Phone
216-973-5227
Email
kachron@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Phone
216-445-8678
Email
mongam@ccf.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Lithotripsy Urolithiasis Machines
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