Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT05993546
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vacuum assisted sheath — DEVICE
    allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
  • passive suction via conventional sheath — DEVICE
    conventional access sheath for stone retrieval using current technique via passive suction

Study Details

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Key Dates

Start date
Aug 29, 2023
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: vacuum-assisted sheath
  • Active Comparator: passive suction via conventional sheath

Primary Outcome Measure

Aim 1: Stone free rate [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Lauren Grimm
[email protected]
216-444-4650

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By research site
Cleveland Clinic· Cleveland, OH

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