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

April 22, 2015 updated by: Ling Li, MD

Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy for the Treatment of Renal Calculi < 3 cm - Efficacity Prospective Randomized Multicentre Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach.

This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.

Study Type

Interventional

Enrollment (Anticipated)

280

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

  • Name: Ling Li, MD
  • Phone Number: 086-18019766513
  • Email: ejdll@163.com

Study Contact Backup

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: tf-URS
Participants in tf-URS group undergo ureteroscopy using the tip-flexible ureterorenoscope.
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.
ACTIVE_COMPARATOR: f-URS
Participants in f-URS group undergo ureteroscopy using the classic flexible ureteroscope.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone clearance
Time Frame: 12 weeks post-operatively
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%
12 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone clearance
Time Frame: One day post-operatively
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%
One day post-operatively
Complication rates
Time Frame: Within 12 weeks after surgery
Number of participants undergo tf-URS or f-URS surgeries suffer complications associated with the surgery (i.e. painess(NRS≥4), hematuria, T≥38℃, serum WBC≥12×〖10〗^9/L ,serum WBC<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%
Within 12 weeks after surgery
Endoscope deflection loss rates
Time Frame: intraoperative
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss>10%/Total number of ureterorenoscope or ureterosocpe used *100%
intraoperative
Endoscope Leakage rates
Time Frame: intraoperative
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with leakage of the working channel or the outer shaft/times of the ureterorenoscope or ureterosocpe used *100%
intraoperative
Endoscope black dots rates
Time Frame: intraoperative
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with black dots on endoscopic images/times of ureterorenoscope or ureterosocpe used *100%
intraoperative

Collaborators and Investigators

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

Sponsor

Ling Li, MD

Collaborators

Changhai Hospital
Xiangya Hospital of Central South University
West China Hospital
The First Affiliated Hospital of Guangzhou Medical University
Ningbo No. 1 Hospital
Yantai Yuhuangding Hospital
Beijing Tsinghua Changgeng Hospital

Investigators

  • Study Chair: Yinghao Sun, MD, Changhai Hospital
  • Principal Investigator: Guohua Zeng, MD, The First Affiliated Hospital of Guangzhou Medical University
  • Principal Investigator: Hequn Chen, MD, Xiangya Hospital of Central South University
  • Principal Investigator: Yue Cheng, MD, Ningbo No. 1 Hospital
  • Principal Investigator: Kunjie Wang, MD, West China Hospital
  • Principal Investigator: Jianxing Li, MD, Beijing Tsinghua Changgeng Hospital
  • Principal Investigator: Lei Shi, MD, Yantai Yuhuangding Hospital
  • Principal Investigator: Xiaofeng Gao, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (ESTIMATE)

April 27, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

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.

Clinical Trials on Renal Calculi

Clinical Trials on the tip-flexible ureterorenoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe