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

Conditions

• Kidney Stones

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 1, 2026

Status verified

May 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2028

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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

• Wilson R. Molina, MD
  913-588-8721
  [email protected]
• Jane Research Project Manager
  913-588-8721
  [email protected]

Locations (1)

Find similar trials in Kansas City, KS

Related Studies

• Pilot Study to Evaluate the Contribution of Gene Variants to Idiopathic Urolithiasis
  Enrolling By Invitation · Mayo Clinic · Jacksonville, Florida
• Oxalate-Driven Host Responses in Kidney Stone Disease
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
• Fecal Microbiota Transplantation in Kidney Stone Patients
  EARLY_PHASE1 · Recruiting · Joshua Stern · Park City, Utah
• Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)
  Recruiting · University of California, San Diego · San Diego, California