Comparing HugeMed Ureteroscope for Kidney Stones

This study is looking at how well a specific flexible ureteroscope, the HugeMed 6.3 Fr f-URS, works compared to other standard ureteroscopes for treating kidney and ureteral stones. Researchers want to see if using the HugeMed device can lead to similar successful stone removal rates while also being more cost-effective. You might be able to join if you are 18 or older, have kidney or ureteral stones, and are having a procedure called retrograde intrarenal surgery (RIRS) where a scope goes up to the kidney. Your total stone size should be 2.5 cm or less. The study will compare outcomes and costs over 36 months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 75 participants. It compares the HugeMed 6.3 Fr f-URS device to traditional approaches for kidney stone treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 36 months to evaluate outcomes and costs.

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NCT07296835

Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope

Recruiting
NAAges 18+InterventionalTreatment
University of Kansas Medical Center
~75 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Ureteroscopy using the 6.3 Fr f-URS hugemedHugemed 6.3 Fr f-URS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS
Measured over 36 months
Kidney Stones
1 sites across 1 states
Kansas1
  • Wilson R. Molina, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

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Eligibility criteria

Inclusion

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

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
  • To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS36 months

    Stone free rate, defined as the absence of residual stone fragments \> 2 mm, as determined by noncontrast CT scan performed