Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07072598
Status
Recruiting
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Conditions

  • Kidney Stones
  • Nephrolithiasis
  • Urolithiasis

Eligibility Criteria

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

Interventions

  • ClearPETRA suction access sheath — DEVICE
    Ureteroscopy utilizing the ClearPETRA suction access sheath.
  • ClearPETRA suction access sheath — DEVICE
    Mini-PCNL utilizing the ClearPETRA suction access sheath

Study Details

The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.

Key Dates

Start date
Apr 25, 2026
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Active Comparator: Ureteroscopy
    Patients randomized to this arm will have their stones treated using the method of Ureteroscopy in a standardized fashion. A second 0.035in sensor guidewire will then be advanced up to the renal pelvis with placement confirmed by fluoroscopy. Placement of a 12/14Fr ClearPETRA ureteral access sheath will be attempted. If this is unsuccessful, a 11/13Fr ClearPETRA ureteral access sheath will be advanced over the wire. If this is unsuccessful, a 5Fr open ended ureteral catheter will be placed and procedure will be converted to a miniPCNL. Lithotripsy will be performed with the MOSES 2.0 high power Holmium laser with settings of 0.3J and 120Hz or 2J and 20Hz depending on stone location and appearance. Stones will be extracted with the suction access sheath. A ureteral stent will be placed at the conclusion of the procedure.
  • Active Comparator: Mini-PCNL
    Will be performed by first starting with supine flexible cystoscopy to cannulate the ureteral orifice with a 5Fr open ended ureteral catheter. The patient will then be repositioned prone with 1-2 bumps placed transversely across the chest. Contrast will be instilled into the ureteral catheter and renal access will be obtained fluoroscopically with the triangulation technique. Once access is obtained, the tract will be dilated to 20Fr and a 18/20Fr ClearPETRA renal access sheath will be inserted to assess the collecting system. If there is concern that the 20Fr access is not sufficient to clear the stone, the tract will be upsized to 24 or 30Fr. The stones will be evacuated with the Trilogy Lithotripter and/or laser, suction and/or basket extraction. A ureteral stent will be placed at the conclusion of the procedure.

Primary Outcome Measure

Stone free rate [ Time Frame: 4 weeks post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Alyssa McDonald, MPH
312-695-8146
Allaa Fadl-Alla, BA
[email protected]
312-695-8146
Amy E Krambeck, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern Memorial Hospital· Chicago, IL

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