Outcomes and costs with the HugeMed 6.3 Fr flexible ureteroscope
Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
This trial will test whether the HugeMed 6.3 Fr flexible ureteroscope gives similar stone-free results while lowering costs compared with traditional flexible ureteroscopes in adults having RIRS for stones up to 2.5 cm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT07296835 on ClinicalTrials.gov |
What this trial studies
This single-center interventional comparison will enroll adults undergoing primary flexible ureteroscopy (retrograde intrarenal surgery) for kidney or ureteral stones with total stone burden ≤ 2.5 cm. Participants will undergo RIRS with either the HugeMed HU30M 6.3 Fr flexible ureteroscope or the institution's traditionally used flexible ureteroscopes, and outcomes including stone-free rate, operative metrics, complications, and device-related costs will be collected. Key exclusions include bilateral procedures during the same operation, genitourinary anatomical abnormalities, uncorrected coagulopathy, urinary diversions, chronic external catheters, pregnancy, immunosuppression, and non-elective cases. The investigators hypothesize that the HU30M will provide comparable stone clearance with potential cost savings and similar safety in this U.S. patient population.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for primary flexible ureteroscopy/RIRS for kidney or ureteral stones with total stone burden ≤ 2.5 cm and who meet standard surgical eligibility are ideal candidates.
Not a fit: Patients needing bilateral treatment in the same procedure, those with complex genitourinary anatomy, urinary diversions, uncorrected bleeding disorders, pregnancy, immunosuppression, or urgent/emergency cases are unlikely to be eligible or to gain benefit from this comparison.
Why it matters
Potential benefit: If successful, patients could get comparable stone clearance with lower procedural costs and potentially less device-related trauma.
How similar studies have performed: Prior reports of smaller-caliber flexible ureteroscopes have shown comparable stone-free rates and reduced ureteral trauma, but direct cost-focused comparisons in U.S. populations are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Kansas
- University Of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Wilson R. Molina, MD — University of Kansas Medical Center
- Study coordinator: Wilson R. Molina, MD
- Email: wmolina@kumc.edu
- Phone: 913-588-8721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.