Recruiting

HU30M vs. f-URS

Sponsor:

University of Kansas Medical Center

Code:

NCT07296835

Conditions

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ureteroscopy using the 6.3 Fr f-URS hugemed

Hugemed 6.3 Fr f-URS

Study Details

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

Study ID

NCT07296835

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Hugemed 6.3 Fr f-URS

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

Primary outcome measure

  • To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Wilson R. Molina, MD

913-588-8721wmolina@kumc.edu

Jane Research Project Manager

913-588-8721jledesma2@kumc.edu

Locations

University Of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160-8500

Contacts

Jane Ledesma

913-588-8721jledesma2@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • hugemed, coast saving, ureteroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-06.