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

University of Kansas

Status: Not yet enrolling

Conditions: Kidney Stones

Treatments: Device: Ureteroscopy using the 6.3 Fr f-URS hugemed; Device: Hugemed 6.3 Fr f-URS

Study type: Interventional

Funder types: Other

Identifiers

NCT07296835

STUDY00161756

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females ³ 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

hugemed ureteroscopy

Active Comparator group

Description:

Patients scheduled to undergo URS retrograde intrarenal surgery per standard of care will be recruited from urology clinics or OR schedules using using the 6.3 Fr f-URS . Patients may be approached and consented in clinic or pre-op. All procedures, devices, and ancillary equipment are standard of care. There is no additional cost to the patient, only the typical standard of care costs. Participants will not be compensated for participation in the study.

Treatment:

Device: Hugemed 6.3 Fr f-URS

Device: Ureteroscopy using the 6.3 Fr f-URS hugemed