Kidney StonesNCT07296835
Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
A study testing Ureteroscopy using the 6.3 Fr f-URS hugemed and Hugemed 6.3 Fr f-URS in people with Kidney Stones, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Ureteroscopy using the 6.3 Fr f-URS hugemed and Hugemed 6.3 Fr f-URS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Of Kansas Medical Center
Kansas City, Kansas, 66160-8500
Jane Ledesma, 913-588-8721, jledesma2@kumc.edu
About this study
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.
- Conditions
- Kidney Stones
- Being tested
- Ureteroscopy using the 6.3 Fr f-URS hugemed, Hugemed 6.3 Fr f-URS
- Keywords
- hugemed, coast saving, ureteroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopy using the 6.3 Fr f-URS hugemedDevice
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-URSDevice
Retrograde intrarenal surgery will be performed using HU30M 6.3 Fr f-URS.
| Study group | Role | What they receive |
|---|---|---|
| hugemed ureteroscopy | Active comparator | 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. Receives: Device: Ureteroscopy using the 6.3 Fr f-URS hugemed; Device: Hugemed 6.3 Fr f-URS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 May 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study employs a hybrid design: a prospective single-arm cohort of patients undergoing RIRS, with outcomes measured at predefined intervals. To provide comparative context, a retrospective control cohort will be identified from KUMC's electronic medical records of patients who also underwent RIRS by SOC with traditional f-URS scope, matched 2:1 based on key baseline characteristics (e.g., age, sex, stone size, etc.). This will allow for retrospective comparison of outcomes between the intervention group and standard management.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- HugeMed
- Responsible party
- Principal investigator, Wilson Molina, University of Kansas Medical Center
- Investigators
- Wilson R. Molina, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296835
- Sponsor's protocol ID
- STUDY00161756
- Status last verified
- May 2026
- First submitted
- 4 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: data will be used to compare different outcomes from ureteroscopy surgeries
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope
- ClinicalTrials.gov ID
- NCT07296835
- Acronym / sponsor ID
- STUDY00161756
- Conditions
- Kidney Stones
- Keywords
- hugemed, coast saving, ureteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- HugeMed
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study employs a hybrid design: a prospective single-arm cohort of patients undergoing RIRS, with outcomes measured at predefined intervals. To provide comparative context, a retrospective control cohort will be identified from KUMC's electronic medical records of patients who also underwent RIRS by SOC with traditional f-URS scope, matched 2:1 based on key baseline characteristics (e.g., age, sex, stone size, etc.). This will allow for retrospective comparison of outcomes between the intervention group and standard management.
| Arm | Type | Receives |
|---|---|---|
| hugemed ureteroscopy | Active comparator | Device: Ureteroscopy using the 6.3 Fr f-URS hugemed, Device: Hugemed 6.3 Fr f-URSPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteroscopy using the 6.3 Fr f-URS hugemedAll 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. | Device | hugemed ureteroscopy |
| Hugemed 6.3 Fr f-URSRetrograde intrarenal surgery will be performed using HU30M 6.3 Fr f-URS. | Device | hugemed ureteroscopy |
Primary outcome
To evaluate and compare outcomes and costs associated with hugeMed 6.3 Fr flexible URS versus traditional approach in RIRS
Time frame: 36 months
Stone free rate, defined as the absence of residual stone fragments > 2 mm, as determined by noncontrast CT scan performed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. data will be used to compare different outcomes from ureteroscopy surgeries
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wilson R. Molina, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy using the 6.3 Fr f-URS hugemed and Hugemed 6.3 Fr f-URS in people with Kidney Stones, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wilson R. Molina, MD (913-588-8721, wmolina@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.