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

NCT ID: NCT07296835

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-11-30

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.

Conditions

Kidney Stones

Keywords

hugemed, coast saving, ureteroscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hugemed ureteroscopy

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.

Group Type: ACTIVE_COMPARATOR

Ureteroscopy using the 6.3 Fr f-URS hugemed

Intervention Type: DEVICE

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.

Hugemed 6.3 Fr f-URS

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Hugemed 6.3 Fr f-URS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson R. Molina, md

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University Of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Central Contacts

Wilson R. Molina, Md

Role: CONTACT

Phone: +13037630909

Email: wmolina@kumc.edu

Briston B. Whiles, md

Role: CONTACT

Phone: +18167693266

Email: bwhiles@kumc.edu

Facility Contacts

Jane Ledesma, manager

Role: primary

Other Identifiers

STUDY00161756

Identifier Type: -

Identifier Source: org_study_id