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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Stones
• Intervention / Treatment: Device: Ureteroscopy using the 6.3 Fr f-URS hugemed; Device: Hugemed 6.3 Fr f-URS

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wilson R. Molina, MD; Phone Number: 913-588-8721; Email: wmolina@kumc.edu
• Study Contact Backup: Name: Jane Research Project Manager; Phone Number: 913-588-8721; Email: jledesma2@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160-8500
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Jane Ledesma; Phone Number: 913-588-8721; Email: jledesma2@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS	Stone free rate, defined as the absence of residual stone fragments > 2 mm, as determined by noncontrast CT scan performed	36 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: HugeMed
• Investigators: Principal Investigator: Wilson R. Molina, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hugemed, coast saving, ureteroscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi
• Other Study ID Numbers: STUDY00161756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be used to compare different outcomes from ureteroscopy surgeries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No