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

University of Kansas Medical Center75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Stones

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 36 months

Central Contacts

Wilson R. Molina, MD

CONTACT

913-588-8721 wmolina@kumc.edu

Jane Research Project Manager