Health TrialsbyHealthPanel

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

ConditionsKidney StonesNephrolithiasisUrolithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years or older

Have a CT scan showing renal stones 1-3cm in length

Patients who will be able to read, understand, and complete patient questionnaires

Disqualifiers

Pregnant individuals

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: UreteroscopyActive comparator 1 intervention
Group B: Mini-PCNLActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone free rate

Stone free rate (no residual stone) on post-procedure CT

Time frame
4 weeks post-procedure

Secondary outcomes

1

Surgery time

Surgery time (minutes)

Time frame
Procedure day (1 day)
2

Complication rate

Complication rate (Clavien-Dindo) (%)

Time frame
Procedure day (1 day)
3

Unplanned hospital visits

Unplanned hospital visits (ED/clinic)

Time frame
90 days postoperatively
4

Need for additional procedure

Need for additional procedure (within 90 days postoperatively)

Time frame
90 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

KARL STORZ Endoscopy-America, Inc.

Collaborator

Source ClinicalTrials.gov
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