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NOT YET RECRUITING
NCT07296835
NA

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

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-12

Completion Date

2028-11

Last Updated

2025-12-22

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Ureteroscopy using the 6.3 Fr f-URS hugemed

All patients will be counseled on standard treatment options. Treatment options and subsequent care will not deviate from routine care. If they do not enroll in the study, the HU30M may still be used during routine surgery and care. The only intervention specific to the research will involve the use of patient information in describing the results. Participants will undergo RIRS in standard fashion, without deviation from the standard of care. Patients will be brought to the operating room, positioned, and placed under general anesthesia. RIRS will be performed using HU30M 6.3 Fr f-URS. Laser platform (ex: HoYAG or TFL) as well as laser settings will be at the treating investigator's discretion and may be changed during the procedure at their discretion as well, all per standard of care. The initial laser settings and changes that occurred to the settings after the first minute of the case will be recorded.

DEVICE

Hugemed 6.3 Fr f-URS

Retrograde intrarenal surgery will be performed using HU30M 6.3 Fr f-URS.

Locations (1)

University Of Kansas Medical Center

Kansas City, Kansas, United States