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NCT Number: NCT07296835

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.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kansas Medical Center

Kansas City, Kansas, 66160-8500, United States

Location status: Recruiting

Location contact

Jane Ledesma

CONTACT

[email protected]

913-588-8721

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ureteroscopy using the 6.3 Fr f-URS hugemed

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

Device

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

Primary outcomes

  1. To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS

    Time frame: 36 months

    Stone free rate, defined as the absence of residual stone fragments > 2 mm, as determined by noncontrast CT scan performed

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Research Project Manager

CONTACT

[email protected]

913-588-8721

Wilson R. Molina, MD

CONTACT

[email protected]

913-588-8721

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • HugeMed

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Dec 22, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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