NCT07296835 Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
| NCT ID | NCT07296835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | Kidney Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2026-05-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Wilson R. Molina, MD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT07296835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07296835 currently recruiting?
Yes, NCT07296835 is actively recruiting participants. Contact the research team at wmolina@kumc.edu for enrollment information.
Where is the NCT07296835 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT07296835 clinical trial?
NCT07296835 is sponsored by University of Kansas Medical Center. The principal investigator is Wilson R. Molina, MD at University of Kansas Medical Center. The trial plans to enroll 75 participants.
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