Comparison of Lithotripsy Urolithiasis Machines (CoLUM)

NeuroTherapia, Inc.

Status: Completed

Conditions: Urolithiasis; Kidney Stone; Ureteral Calculi; Ureterolithiasis; Kidney Calculi

Treatments: Procedure: Lithotripter

Study type: Interventional

Funder types: Other

Identifiers

NCT04069338

19-619

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Device Storz Modulith SLX-F2

Active Comparator group

Description:

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

Treatment:

Procedure: Lithotripter

Dornier Delta III Treatment

Active Comparator group

Description:

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

Treatment:

Procedure: Lithotripter