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Not yet recruitingNCT06914986Updated Apr 7, 2025

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

An interventional study of Performed flexible and navigable suction ureteral access sheath combined with needle perc and PCNL in Urinary Calculi, sponsored by Beijing Tsinghua Chang Gung Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-07.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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
02

Conditions studied

  • Urinary Calculi

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Keywords

  • partial staghorn renal calculi
03

In context

Urinary Calculi

94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.

This study's planned enrollment of 344 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.

Browse Urinary Calculi studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 18-80 years
  2. CT scan indicates partial staghorn calculi
  3. Able to complete the study in accordance with the protocol requirements
  4. Informed about the study and has signed the form

Exclusion criteria

Exclusion Criteria:

  1. Severe renal insufficiency ( \< 30 ml/min/1.73 m²)
  2. Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
  3. Renal stone volume > 33.5 cm³
  4. 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.
  5. Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
  6. History of previous open renal stone surgery
  7. Patients with uncontrolled urinary tract infections
  8. Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
344 participants (estimated)

Study arms

  • Experimental
    flexible and navigable suction ureteral access sheath combined with needle perc

    Procedure: Performed flexible and navigable suction ureteral access sheath combined with needle perc

  • Other
    PCNL group

    Procedure: PCNL

Interventions

  • ProcedurePerformed flexible and navigable suction ureteral access sheath combined with needle perc

    Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

  • ProcedurePCNL

    Patients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

06

What researchers measure

Primary outcomes

  1. stone free rate

    Patient will have CT scan 3 month after surgery

    Time frame: 3 month after surgery

Secondary outcomes

  1. complications

    Patients were recorded complications after surgery

    Time frame: 3 month after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914986
Responsible party
Sponsor
First posted
Apr 7, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Apr 7, 2025

Study contacts

bo xiao, M.D.
Contact
beidaxiaobo@163.com
86+13811403056

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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