Comparison of Lithotripsy Urolithiasis Machines

Urolithiasis Clinical Trial

— CoLUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069338
• Other study ID #: 19-619
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: October 12, 2022

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis
• Urinary Calculi
• Urolithiasis

Intervention

Procedure:
• Lithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	Presence of stone on follow up imaging	Four weeks post operative
Secondary	Fluoroscopy time	Length of fluoroscopy exposure	Intra-operative
Secondary	Treatment Time	Length of surgical procedure	Intra-operative
Secondary	Pain Scores	Response to visual analog scale	Four days post-operative
Secondary	Complication Rates	Medical complications	One month post-operative
Secondary	Secondary Interventions required	Follow up surgery	One month post-operative