Renal Calculi (Kidney Stones) ≤ 20 mmNCT07371494
Super-Mini Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy for Renal Stones 20 mm or Less
A study testing Super-mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy in people with Renal Calculi (Kidney Stones) ≤ 20 mm, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
Kidney stones measuring 20 mm or less are commonly managed using minimally invasive surgical techniques. Two widely used approaches are Super-mini Percutaneous Nephrolithotomy (SMP) and Flexible Ureteroscopy (fURS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi (Kidney Stones) ≤ 20 mm
- What is being tested?
- Super-mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients (≥18 years of age).
- Patients with renal stones measuring ≤20 mm in maximal diameter on preoperative imaging.
- No prior surgical or interventional procedure during the same hospital admission.
- Ability and willingness to provide written informed consent.
Who cannot join
- Pregnancy.
- Coagulation disorders or bleeding diathesis contraindicating surgery.
- Contraindications to either Super-mini Percutaneous Nephrolithotomy (SMP) or Flexible Ureteroscopy (fURS).
- Patients undergoing SMP or fURS for ureteral stones that migrated back into the kidney.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Super-Mini Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy for Renal Stones 20 mm or Less: A Single-Center Randomized Controlled Trial Assessing Cost Analysis and Safety in Northern Vietnam
Kidney stones measuring 20 mm or less are commonly managed using minimally invasive surgical techniques. Two widely used approaches are Super-mini Percutaneous Nephrolithotomy (SMP) and Flexible Ureteroscopy (fURS). Although both techniques are considered effective and safe, they differ in surgical approach, use of disposable equipment, postoperative recovery, and treatment cost. In resource-limited settings, economic considerations may play an important role in treatment selection.
This single-center randomized controlled trial was conducted at Bach Mai Hospital, Hanoi, Vietnam, to compare clinical outcomes, safety, and direct medical costs of SMP versus fURS in patients with renal stones ≤20 mm. Eligible patients were randomly assigned in a 1:1 ratio to undergo either SMP or fURS.
The primary outcome was the stone-free rate assessed by postoperative imaging. Secondary outcomes included operative time, postoperative complications, length of hospital stay, hemoglobin drop, and total direct treatment cost per case. The results of this study aim to provide evidence to support clinical decision-making for the management of renal stones, particularly in healthcare settings with limited resources.
- Conditions
- Renal Calculi (Kidney Stones) ≤ 20 mm
- Being tested
- Super-mini Percutaneous Nephrolithotomy, Flexible 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.
Super-mini Percutaneous NephrolithotomyProcedure or surgery
Surgical removal of renal stones using super-mini PCNL technique
Flexible UreteroscopyProcedure or surgery
Endoscopic treatment of renal stones using flexible ureteroscope
| Study group | Role | What they receive |
|---|---|---|
| SMP group | Experimental | Not described Receives: Procedure: Super-mini Percutaneous Nephrolithotomy |
| fURS group | Experimental | Not described Receives: Procedure: Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate (SFR)
Stone-free rate was defined as the absence of residual stone fragments >4 mm in maximal diameter on postoperative imaging. Stone-free status was assessed using plain abdominal radiography (KUB) on postoperative day 1 and non-contrast computed tomography (CT) at 1 month after surgery. The stone-free rate was determined based on the 1-month CT findings.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Calculi (Kidney Stones) ≤ 20 mmStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371494
- Sponsor's protocol ID
- No. 876/GCN-HĐĐĐNCYSH-ĐHYHN
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-Mini Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy for Renal Stones 20 mm or Less: A Single-Center Randomized Controlled Trial Assessing Cost Analysis and Safety in Northern Vietnam
- ClinicalTrials.gov ID
- NCT07371494
- Acronym / sponsor ID
- No. 876/GCN-HĐĐĐNCYSH-ĐHYHN
- Conditions
- Renal Calculi (Kidney Stones) ≤ 20 mm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jan 2026 (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.
Kidney stones measuring 20 mm or less are commonly managed using minimally invasive surgical techniques. Two widely used approaches are Super-mini Percutaneous Nephrolithotomy (SMP) and Flexible Ureteroscopy (fURS). Although both techniques are considered effective and safe, they differ in surgical approach, use of disposable equipment, postoperative recovery, and treatment cost. In resource-limited settings, economic considerations may play an important role in treatment selection.
This single-center randomized controlled trial was conducted at Bach Mai Hospital, Hanoi, Vietnam, to compare clinical outcomes, safety, and direct medical costs of SMP versus fURS in patients with renal stones ≤20 mm. Eligible patients were randomly assigned in a 1:1 ratio to undergo either SMP or fURS.
The primary outcome was the stone-free rate assessed by postoperative imaging. Secondary outcomes included operative time, postoperative complications, length of hospital stay, hemoglobin drop, and total direct treatment cost per case. The results of this study aim to provide evidence to support clinical decision-making for the management of renal stones, particularly in healthcare settings with limited resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMP group | Experimental | Procedure: Super-mini Percutaneous Nephrolithotomy |
| fURS group | Experimental | Procedure: Flexible Ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years of age).
- Patients with renal stones measuring ≤20 mm in maximal diameter on preoperative imaging.
- No prior surgical or interventional procedure during the same hospital admission.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (4 listed)
- Pregnancy.
- Coagulation disorders or bleeding diathesis contraindicating surgery.
- Contraindications to either Super-mini Percutaneous Nephrolithotomy (SMP) or Flexible Ureteroscopy (fURS).
- Patients undergoing SMP or fURS for ureteral stones that migrated back into the kidney.
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 |
|---|---|---|
| Super-mini Percutaneous NephrolithotomySurgical removal of renal stones using super-mini PCNL technique | Procedure or surgery | SMP group |
| Flexible UreteroscopyEndoscopic treatment of renal stones using flexible ureteroscope | Procedure or surgery | fURS group |
Primary outcome
Stone-free rate (SFR)
Time frame: 1 month after surgery
Stone-free rate was defined as the absence of residual stone fragments >4 mm in maximal diameter on postoperative imaging. Stone-free status was assessed using plain abdominal radiography (KUB) on postoperative day 1 and non-contrast computed tomography (CT) at 1 month after surgery. The stone-free rate was determined based on the 1-month CT findings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super-mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy in people with Renal Calculi (Kidney Stones) ≤ 20 mm, run by Hanoi Medical University at 1 site in Vietnam.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (SFR) (time frame: 1 month after surgery). 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 21 Sep 2026.