A Prospective Multicenter Randomized Controlled Trial of... | NCT06914986

Studies
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

NCT06914986

Sponsor

Beijing Tsinghua Chang Gung Hospital

Status

Not yet recruiting

Last Update Posted

Apr 7, 2025Actual

Enrollment

344Estimated

Phase

Not Applicable

Conditions

Urinary Calculi

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

Apr 1, 2025

First Submission Date that Met QC Criteria

Apr 1, 2025

First Posted Date

Apr 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2025

Last Update Posted Date

Apr 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

344Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Performed flexible and navigable suction ureteral access sheath combined with needle perc	Procedure	Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stone free rate	Patient will have CT scan 3 month after surgery	3 month after surgery

Secondary Outcomes

Measure	Description	Time Frame
complications	Patients were recorded complications after surgery	3 month after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
bo xiao, M.D.	Contact	86+13811403056		beidaxiaobo@163.com

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D014545	Urinary Calculi

Ancestor Terms

ID	Term
D052878	Urolithiasis
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002137	Calculi
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms