Comparison of Lithotripsy Urolithiasis Machines (CoLUM)

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

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

Study Overview

• Status: Completed
• Conditions: Kidney Calculi; Urolithiasis; Ureteral Calculi; Ureterolithiasis; Kidney Stone
• Intervention / Treatment: Procedure: Lithotripter

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manoj Monga, MD; Phone Number: 216 445-8678; Email: mongam@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Presence of stone on follow up imaging	Four weeks post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopy time	Length of fluoroscopy exposure	Intra-operative
Treatment Time	Length of surgical procedure	Intra-operative
Pain Scores	Response to visual analog scale	Four days post-operative
Complication Rates	Medical complications	One month post-operative
Secondary Interventions required	Follow up surgery	One month post-operative

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Manoj Monga, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Lithotripsy; Extracorporeal shockwave lithotripsy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis; Calculi; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: 19-619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No