Outcomes and costs with the HugeMed 6.3 Fr flexible ureteroscope

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional comparison will enroll adults undergoing primary flexible ureteroscopy (retrograde intrarenal surgery) for kidney or ureteral stones with total stone burden ≤ 2.5 cm. Participants will undergo RIRS with either the HugeMed HU30M 6.3 Fr flexible ureteroscope or the institution's traditionally used flexible ureteroscopes, and outcomes including stone-free rate, operative metrics, complications, and device-related costs will be collected. Key exclusions include bilateral procedures during the same operation, genitourinary anatomical abnormalities, uncorrected coagulopathy, urinary diversions, chronic external catheters, pregnancy, immunosuppression, and non-elective cases. The investigators hypothesize that the HU30M will provide comparable stone clearance with potential cost savings and similar safety in this U.S. patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males or females ≥ 18 years of age
* Patients with ureteral or kidney stones undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
* Total stone burden ≤ 2.5 cm

Exclusion Criteria:

* Undergoing bilateral stone treatment during the same procedure
* Patients with known genitourinary anatomical abnormalities that would complicate the procedure as determined by the treating investigator
* Uncorrected coagulopathy
* Patients with urinary diversions
* Chronic external urinary catheters
* Women who are pregnant
* Immunosuppressed patients
* Non-elective procedures
* Participants must not be involved in any other clinical research studies during the duration of this trial. Exceptions may be made if the investigator determines, on a case-by-case basis, that participation in another study will not adversely affect the outcomes or integrity of this trial

Where it's running

• University Of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Principal investigator: Wilson R. Molina, MD — University of Kansas Medical Center
• Study coordinator: Wilson R. Molina, MD
• Email: wmolina@kumc.edu
• Phone: 913-588-8721

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.