Urinary CalculiNCT06914986
A Prospective Multicenter Randomized Controlled Trial of Flexible And Navigable Suction Ureteral Access Sheath Combined With Needle Perc for the Treatment of Partial Staghorn Renal Calculi
A study testing Performed flexible and navigable suction ureteral access sheath combined with needle perc and PCNL in people with Urinary Calculi, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about the safety of drug ABC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Calculi
- What is being tested?
- Performed flexible and navigable suction ureteral access sheath combined with needle perc and PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years
- CT scan indicates partial staghorn calculi
- Able to complete the study in accordance with the protocol requirements
- Informed about the study and has signed the informed consent form
Who cannot join
- Severe renal insufficiency (GFR < 30 ml/min/1.73 m²)
- Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
- Renal stone volume > 33.5 cm³
- Renal stones or nephrocalcinosis caused by genetic diseases or definite metabolic disorders that have not been ruled out, such as renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc.
- Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
- History of previous open renal stone surgery
- Patients with uncontrolled urinary tract infections
- Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about the safety of drug ABC. The main questions it aims to answer are:
- Does flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL
- Does flexible and navigable suction ureteral access sheath combined with needle perc result in more complications compared with PCNL Researchers will compare flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL to see if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi.
Read more
Participants will:
- Performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
- Visit the clinic after surgery 1 month and 3 month for checkups and tests
- Conditions
- Urinary Calculi
- Being tested
- Performed flexible and navigable suction ureteral access sheath combined with needle perc, PCNL
- Keywords
- partial staghorn renal calculi
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performed flexible and navigable suction ureteral access sheath combined with needle percProcedure or surgery
Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
PCNLProcedure or surgery
Patients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
| Study group | Role | What they receive |
|---|---|---|
| flexible and navigable suction ureteral access sheath combined with needle perc | Experimental | Not described Receives: Procedure: Performed flexible and navigable suction ureteral access sheath combined with needle perc |
| PCNL group | Other | Not described Receives: Procedure: PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
Patient will have CT scan 3 month after surgery
Measured: 3 month after surgery
Secondary outcomes (1)
complications
Patients were recorded complications after surgery
Measured: 3 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 posted7 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Multicenter Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914986
- Sponsor's protocol ID
- 24747-0-02
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2025
- Last updated
- 7 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Trial of Flexible And Navigable Suction Ureteral Access Sheath Combined With Needle Perc for the Treatment of Partial Staghorn Renal Calculi
- ClinicalTrials.gov ID
- NCT06914986
- Acronym / sponsor ID
- 24747-0-02
- Conditions
- Urinary Calculi
- Keywords
- partial staghorn renal calculi
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Apr 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.
The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about the safety of drug ABC. The main questions it aims to answer are:
- Does flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL
- Does flexible and navigable suction ureteral access sheath combined with needle perc result in more complications compared with PCNL Researchers will compare flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL to see if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi.
Participants will:
- Performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
- Visit the clinic after surgery 1 month and 3 month for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Prospective Multicenter Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| flexible and navigable suction ureteral access sheath combined with needle perc | Experimental | Procedure: Performed flexible and navigable suction ureteral access sheath combined with needle perc |
| PCNL group | Other | Procedure: PCNL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-80 years
- CT scan indicates partial staghorn calculi
- Able to complete the study in accordance with the protocol requirements
- Informed about the study and has signed the informed consent form
Key exclusion criteria (8 listed)
- Severe renal insufficiency (GFR < 30 ml/min/1.73 m²)
- Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
- Renal stone volume > 33.5 cm³
- Renal stones or nephrocalcinosis caused by genetic diseases or definite metabolic disorders that have not been ruled out, such as renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc.
- Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
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 |
|---|---|---|
| Performed flexible and navigable suction ureteral access sheath combined with needle percPatients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL | Procedure or surgery | flexible and navigable suction ureteral access sheath combined with needle perc |
| PCNLPatients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL | Procedure or surgery | PCNL group |
Primary outcome
stone free rate
Time frame: 3 month after surgery
Patient will have CT scan 3 month after surgery
1 secondary outcome
complications
Time frame: 3 month after surgery
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 7 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Performed flexible and navigable suction ureteral access sheath combined with needle perc and PCNL in people with Urinary Calculi, run by Beijing Tsinghua Chang Gung Hospital.
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 8 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: opening soon, as of the sponsor's last update on 7 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 bo xiao, M.D. (86+13811403056, beidaxiaobo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate (time frame: 3 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 7 Apr 2025.