About this trial
Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS devices in RIRS are lacking in an American population. The investigators aim to compare the outcomes of using the 6.3 Fr f-URS versus traditional approach (other f-URS present in our institution) to treat patients with stone burden ≤ 2.5 cm. The findings of this study will expand on the potential advantages and drawbacks of HU30M in enhancing surgical outcomes and patient safety in RIRS procedures. We hypothesize that the use of the HU30M will result in increased cost savings while providing similar stone free rates when compared to traditionally used f-URS devices.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ureteroscopy using the 6.3 Fr f-URS hugemed
- Hugemed 6.3 Fr f-URS
Treatment groups
Sponsors and collaborators
University of Kansas Medical Center
Lead sponsor
HugeMed
Collaborator