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

April 1, 2025 updated by: Beijing Tsinghua Chang Gung Hospital

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 informed consent form

Exclusion Criteria:

  1. Severe renal insufficiency (GFR < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
Other: PCNL group
Procedure: PCNL
Patients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 7, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24747-0-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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