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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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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