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

RecruitingNAAges 18 Years - anyAllUniversity of Kansas Medical Center
NCT07296835 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Ureteroscopy using the 6.3 Fr f-URS hugemed
  • Hugemed 6.3 Fr f-URS
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Where

1 site
University Of Kansas Medical Center
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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