Ureteroscopy for Kidney Stones
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device for removing kidney stones using a procedure called ureteroscopy. Researchers aim to determine if the HugeMed 6.3 Fr f-URS device is as effective and safe as traditional devices used in this surgery. The study focuses on individuals with kidney stones that are 2.5 cm or smaller and seeks to find out if this new device can lead to cost savings while effectively removing the stones. Those with kidney or ureter stones scheduled for this specific surgery might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to medical advancements and potentially benefit from innovative treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the HugeMed HU30M 6.3 Fr f-URS device is safe for ureteroscopy procedures?
Research has shown that the HugeMed 6.3 Fr ureteroscope is safe for treating kidney stones. One study found it as safe as the 7.5 Fr model. Patients handled the procedure well, experiencing no additional complications. Another study found that some patients could go home the same day after using the 6.3 Fr ureteroscope, indicating it is a gentle option. Overall, the device appears safe and well-tolerated for those needing kidney stone treatment.12345
Why are researchers excited about this trial?
Researchers are excited about the ureteroscopy procedure using the Hugemed 6.3 Fr f-URS because it offers a more precise and potentially less invasive option for removing kidney stones. Unlike traditional ureteroscopy tools, this method employs a smaller, flexible ureteroscope, which may reduce discomfort and recovery time for patients. Additionally, the procedure is integrated into the standard of care, meaning it doesn't introduce extra costs or risks to patients, making it an attractive and accessible option for improving kidney stone treatment.
What evidence suggests that the Hugemed 6.3 Fr f-URS is effective for treating kidney stones?
Research shows that the Hugemed 6.3 Fr ureteroscope, used by participants in this trial, effectively treats kidney stones. Studies indicate it performs as well as or better than the larger 7.5 Fr model in clearing stones. It is particularly beneficial for patients on blood thinners, as it reduces the risk of bleeding and injury to the ureter, the tube connecting the kidneys to the bladder. The device has successfully removed stones, even in complex cases involving additional kidney structures. Overall, the 6.3 Fr model offers a safe and efficient option for managing kidney stones.15678
Who Is on the Research Team?
Wilson R. Molina, md
Principal Investigator
University of Kansas Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with kidney stones (nephrolithiasis) or struvite stones, specifically those with stone burden ≤ 2.5 cm. The study will compare a new type of ureteroscope called the HugeMed HU30M 6.3 Fr f-URS to traditional devices used in RIRS procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo URS retrograde intrarenal surgery using the 6.3 Fr f-URS or traditional f-URS devices
Follow-up
Participants are monitored for surgical outcomes and stone-free rates
What Are the Treatments Tested in This Trial?
Interventions
- Hugemed 6.3 Fr f-URS
- Ureteroscopy using the 6.3 Fr f-URS hugemed
Trial Overview
The trial is testing the effectiveness and cost-efficiency of using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope (f-URS) compared to traditional f-URS devices during Retrograde Intrarenal Surgery (RIRS). It aims to determine if this new device can provide similar outcomes while saving costs.
How Is the Trial Designed?
1
Treatment groups
Active Control
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
Citations
Early clinical outcomes using a 6.3 Fr single ... - Nature
This study highlights the safety and efficacy of the 6.3 Fr ureteroscope, demonstrating comparable or superior outcomes to the 7.5 Fr model in terms of SFR and ...
First clinical application of the novel 6.3 Fr disposable ...
The 6.3 Fr disposable digital flexible ureteroscope is effective for managing renal stones in anticoagulant patients, reducing bleeding risks, ureteral injury, ...
3.
researchgate.net
researchgate.net/publication/391401131_Early_clinical_outcomes_using_a_63_Fr_single_use_ureteroscope_compared_to_a_75_Fr_device(PDF) Early clinical outcomes using a 6.3 Fr single ...
This prospective, single-center study compared the performance of the 6.3 Fr single-use flexible ureteroscope to the 7.5 Fr model in the treatment of kidney ...
First use and evaluation of a novel 6.3 Fr disposable flexible ...
This report documents the successful stone removal in a patient with duplex kidney complicated with a ureteric and renal stones using a novel 6.3 Fr dd-FURS, ...
5.
cdn.amegroups.cn
cdn.amegroups.cn/journals/amepc/files/journals/3/articles/131429/public/131429-PB9-2778-R3.pdf?filename=tau-13-11-2644.pdf&t=1750766702First use and evaluation of a novel 6.3 Fr disposable ...
This report documents the successful stone removal in a patient with duplex kidney complicated with a ureteric and renal stones using a novel ...
Surgical Outcomes and Costs in Using the Shenzhen ...
Study Overview. Brief Summary. Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS ...
Clinical Outcomes and Safety Assessment of Flexible ...
This retrospective study investigates the feasibility of same-day discharge following fURS procedures performed under SA.
Feasibility and Safety of Primary Ureteroscopy with Single ...
This study aims to evaluate the feasibility and safety of primary ureteroscopy using the HU30M (6.3 Fr, HugeMed, Shenzhen HugeMed Medical Technical Development ...
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