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NCT Number: NCT07072598

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Allaa Fadl-Alla, BA

CONTACT

[email protected]

312-695-8146

Alyssa McDonald, MPH

CONTACT

312-695-8146

Amy E Krambeck, MD

PRINCIPAL_INVESTIGATOR

About this study

With the advent of mini-PCNLs, some endourologists have been utilizing the technique to treat renal calculi up to 3cm in size with better stone free rates and similar comorbidity compared to ureteroscopy. These procedures require percutaneous renal access, and it is associated with greater length of stay and fluoroscopy time.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

ClearPETRA suction access sheath

Device

Ureteroscopy utilizing the ClearPETRA suction access sheath.

Primary outcomes

  1. Stone free rate

    Time frame: 4 weeks post-procedure

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

Secondary outcomes

  1. Surgery time

    Time frame: Procedure day (1 day)

    Surgery time (minutes)

  2. Complication rate

    Time frame: Procedure day (1 day)

    Complication rate (Clavien-Dindo) (%)

  3. Unplanned hospital visits

    Time frame: 90 days postoperatively

    Unplanned hospital visits (ED/clinic)

  4. Need for additional procedure

    Time frame: 90 days postoperatively

    Need for additional procedure (within 90 days postoperatively)

  5. Length of stay

    Time frame: Perioperatively (starting at Baseline/Procedure Date)

    Length of stay hospital stay (if admitted post-procedure, or readmitted)

  6. Inability to access ureter

    Time frame: Procedure day (1 day)

    Intra-operative complications including inability to access the ureter ureteroscopically or need to upsize the renal access sheath with the percutaneous approach.

  7. Need to upsize from 18Fr Sheath

    Time frame: Procedure day (1 day)

    Need to upsize from 18Fr (PCNL group)

  8. Occurrence of post-procedure sepsis

    Time frame: Perioperatively (starting at Baseline/Procedure Date)

    Post-op sepsis

  9. Hospital / patient costs (in total for procedure and any necessary postoperative hospital admissions or procedures related to the initial procedure).

    Time frame: Perioperatively (starting at Baseline/Procedure Date)

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa McDonald, MPH

CONTACT

[email protected]

312-695-8146

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • KARL STORZ Endoscopy-America, Inc.

Registry information

Official study title

Comparing Efficiency and Stone-Free Rates After Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Access Sheaths

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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