Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS
NCT ID: NCT07072598
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
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Detailed Description
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The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the benefits of mini-PCNL without the added risk associated with obtaining percutaneous renal access.
The ClearPETRA flexible suction ureteral access sheath anecdotally improves efficiency and allows endourologists to better clear stone debris when compared to traditional ureteral access sheaths. We have yet to see a comparison between suction ureteral access sheaths and mini-PCNL with the suction renal access sheath.
Study Hypothesis: Compared to traditional access sheaths, using ClearPETRA access sheaths will result in an improvement in stone free rates with both modalities, with lower complications. Using ClearPETRA access sheaths in both modalities compared to traditional access sheaths should result in less of a difference in stone free rates between the ureteroscopy group and the mini-PCNL group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
ClearPETRA suction access sheath
Ureteroscopy utilizing the ClearPETRA suction access sheath.
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.
ClearPETRA suction access sheath
Mini-PCNL utilizing the ClearPETRA suction access sheath
Interventions
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ClearPETRA suction access sheath
Ureteroscopy utilizing the ClearPETRA suction access sheath.
ClearPETRA suction access sheath
Mini-PCNL utilizing the ClearPETRA suction access sheath
Eligibility Criteria
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Inclusion Criteria
* Have a CT scan showing renal stones 1-3cm in length
* Patients who will be able to read, understand, and complete patient questionnaires
Exclusion Criteria
* Those with anomalous renal anatomy
* Patients with a urinary diversion (ex: Ileal conduit, reservoir, bladder substitute, etc.)
* Any condition rendering patient medically unfit to undergo either procedure (Bleeding diasthesis)
* Patients who lack decisional capacity
* Patients who are non-english speakers\*
* Non-recruitment of non-english speakers is due to the study being a small pilot study that is used to assess the stone free rate for patients treated with a ureteroscopy or mini-PCNL using ClearPETRA suction access sheaths in a small portion of our patient population seeking treatment for stones. The team also does not possess the bandwidth or personnel to consent patients who are non-English speaking.
18 Years
ALL
No
Sponsors
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KARL STORZ Endoscopy-America, Inc.
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Amy Krambeck
Director of the Endourology/Stone Division
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Alyssa McDonald, MPH
Role: primary
Other Identifiers
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STU00222993
Identifier Type: -
Identifier Source: org_study_id
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