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

Primary Purpose

Renal Calculi

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

the tip-flexible ureterorenoscope

the classic flexible ureteroscope

About this trial

This is an interventional treatment trial for Renal Calculi focused on measuring retrograde intrarenal surgery, flexible ureteroscopy, renal calculi

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tf-URS

f-URS

Arm Description

Participants in tf-URS group undergo ureteroscopy using the tip-flexible ureterorenoscope.

Participants in f-URS group undergo ureteroscopy using the classic flexible ureteroscope.

Outcomes

Primary Outcome Measures

Stone clearance

Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%

Secondary Outcome Measures

Stone clearance

Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%

Complication rates

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%

Endoscope deflection loss rates

Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss>10%/Total number of ureterorenoscope or ureterosocpe used *100%

Endoscope Leakage rates

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%

Endoscope black dots rates

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%

Full Information

NCT ID

NCT02426931

First Posted

February 12, 2015

Last Updated

April 22, 2015

Sponsor

Ling Li, MD

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02426931

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ling Li, MD

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Calculi

Keywords

retrograde intrarenal surgery, flexible ureteroscopy, renal calculi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tf-URS

Arm Type

Experimental

Arm Description

Participants in tf-URS group undergo ureteroscopy using the tip-flexible ureterorenoscope.

Arm Title

f-URS

Arm Type

Active Comparator

Arm Description

Participants in f-URS group undergo ureteroscopy using the classic flexible ureteroscope.

Intervention Type

Device

Intervention Name(s)

the tip-flexible ureterorenoscope

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

the classic flexible ureteroscope

Intervention Description

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.

Primary Outcome Measure Information:

Title

Stone clearance

Description

Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%

Time Frame

12 weeks post-operatively

Secondary Outcome Measure Information:

Title

Stone clearance

Description

Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%

Time Frame

One day post-operatively

Title

Complication rates

Description

Time Frame

Within 12 weeks after surgery

Title

Endoscope deflection loss rates

Description

Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss>10%/Total number of ureterorenoscope or ureterosocpe used *100%

Time Frame

intraoperative

Title

Endoscope Leakage rates

Description

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%

Time Frame

intraoperative

Title

Endoscope black dots rates

Description

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%

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ling Li, MD

Phone

086-18019766513

ejdll@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yonghan Peng, MD

Phone

086-13917386896

yonghanyhtl@163.com

Overall Study Officials: