Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ureteroscopy using the 6.3 Fr f-URS hugemed, Hugemed 6.3 Fr f-URS.
- Who it may be relevant to
- Registry conditions: Kidney Stones. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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, posi - Device Hugemed 6.3 Fr f-URS
Retrograde intrarenal surgery will be performed using HU30M 6.3 Fr f-URS.
Primary outcome measures
- To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT07296835 · STUDY00161756