Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Location status: Recruiting
Location contact
Allaa Fadl-Alla, BA
CONTACT
Alyssa McDonald, MPH
CONTACT
Amy E Krambeck, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07072598
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
Allaa Fadl-Alla, BA
CONTACT
Alyssa McDonald, MPH
CONTACT
Amy E Krambeck, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ureteroscopy utilizing the ClearPETRA suction access sheath.
Time frame: 4 weeks post-procedure
Stone free rate (no residual stone) on post-procedure CT
Time frame: Procedure day (1 day)
Surgery time (minutes)
Time frame: Procedure day (1 day)
Complication rate (Clavien-Dindo) (%)
Time frame: 90 days postoperatively
Unplanned hospital visits (ED/clinic)
Time frame: 90 days postoperatively
Need for additional procedure (within 90 days postoperatively)
Time frame: Perioperatively (starting at Baseline/Procedure Date)
Length of stay hospital stay (if admitted post-procedure, or readmitted)
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.
Time frame: Procedure day (1 day)
Need to upsize from 18Fr (PCNL group)
Time frame: Perioperatively (starting at Baseline/Procedure Date)
Post-op sepsis
Time frame: Perioperatively (starting at Baseline/Procedure Date)
Contact information is provided by the study sponsor or research team.
Northwestern University
Other
Comparing Efficiency and Stone-Free Rates After Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Access Sheaths
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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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