Comparison of Holmium Laser and Thulium Laser for Mini PCNL

Part of paid clinical trials in Portland, Maine.

Sponsor
MaineHealth
Study ID
NCT06266793
Status
Enrolling By Invitation

Conditions

  • Nephrolithiasis
  • Percutaneous Nephrolithotomy

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Holmium Laser — DEVICE
    Assigned to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser.
  • Thulium Laser — DEVICE
    Assigned to be treated using the Olympus Soltive Thulium SuperPulsed Fiber Laser

Study Details

This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting.

Key Dates

Start date
Mar 7, 2024
Status verified
Feb 2024
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Holmium Laser
    Participants in this arm are randomized to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser
  • Active Comparator: Thulium Laser
    Participants in this arm are randomized to be treated using the Olympus Soltive SuperPulsed Thulium Fiber Laser

Primary Outcome Measure

Laser Treatment Time [ Time Frame: The duration of the procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Maine Medical CenterPortlandMaine04102-

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By research site
Maine Medical Center· Portland, ME

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