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

NCT02426931 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2015-04-27

No results posted yet for this study

Summary

This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.

Conditions

  • Renal Calculi

Interventions

DEVICE

the tip-flexible ureterorenoscope

Ureteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique.

DEVICE

the classic flexible ureteroscope

Ureteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique.

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Ningbo No. 1 Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Beijing Tsinghua Changgeng Hospital

    collaborator OTHER

  • Yantai Yuhuangding Hospital

    collaborator OTHER

  • Ling Li, MD

    lead OTHER

Principal Investigators

  • Yinghao Sun, MD · Changhai Hospital

  • Guohua Zeng, MD · The First Affiliated Hospital of Guangzhou Medical University

  • Hequn Chen, MD · Xiangya Hospital of Central South University

  • Yue Cheng, MD · Ningbo No. 1 Hospital

  • Kunjie Wang, MD · West China Hospital

  • Jianxing Li, MD · Beijing Tsinghua Changgeng Hospital

  • Lei Shi, MD · Yantai Yuhuangding Hospital

  • Xiaofeng Gao, MD · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426931 on ClinicalTrials.gov