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Search / Trial NCT02426931

Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy in Renal Calculi

Launched by LING LI, MD · Apr 22, 2015

Trial Information

Current as of June 19, 2025

Unknown status

Keywords

Retrograde Intrarenal Surgery Flexible Ureteroscopy Renal Calculi

ClinConnect Summary

Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi \< 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.

However, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution.

Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subject has provided informed consent and indicated a willingness to comply with study treatments
  • Subject has a diagnosis of renal stones according to computer tomography (CT) and intravenous pyelogram (IVP) results
  • Subject is a surgical candidate for the ureteroscopic approach
  • Subject is 18-80 yrs of age
  • Subject has a single stone \< 3 cm in size (IVP), or multiple stones \< 3 cm in cumulative size (IVP)
  • Subject has a serum creatinine level within the normal range for the study center
  • Exclusion Criteria:
  • Subject needs bilateral procedures within one-stage ureteroscopy
  • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
  • Subject has been diagnosed with a urethral stricture or bladder neck contracture
  • Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
  • Subject has severe hematuria that might blur the vision of the endoscopy
  • Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
  • Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
  • Subject has other diseases and could not tolerate the endoscopic surgery
  • Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
  • Subject has ipsilateral pre-stenting or previous ureteroscopy within six months
  • Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination

About Ling Li, Md

Dr. Ling Li, MD, is a distinguished clinical trial sponsor with a robust background in medical research and patient care. With expertise spanning multiple therapeutic areas, Dr. Li is dedicated to advancing clinical knowledge and innovative treatment options through rigorous trial design and implementation. Committed to ethical standards and regulatory compliance, Dr. Li fosters collaborative partnerships with academic institutions and industry stakeholders to ensure the successful execution of trials. Through a patient-centered approach, Dr. Li focuses on enhancing outcomes and improving healthcare delivery, contributing to the evolution of evidence-based medicine.

Locations

Patients applied

0 patients applied

Trial Officials

Yinghao Sun, MD

Study Chair

Changhai Hospital

Guohua Zeng, MD

Principal Investigator

The First Affiliated Hospital of Guangzhou Medical University

Hequn Chen, MD

Principal Investigator

Xiangya Hospital of Central South University

Yue Cheng, MD

Principal Investigator

Ningbo No. 1 Hospital

Kunjie Wang, MD

Principal Investigator

West China Hospital

Jianxing Li, MD

Principal Investigator

Beijing Tsinghua Changgeng Hospital

Lei Shi, MD

Principal Investigator

Yantai Yuhuangding Hospital

Xiaofeng Gao, MD

Principal Investigator

Changhai Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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