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Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure

Primary Purpose

Renal Calculi

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SF-URS with automatic control of RPP
conventional F-URS
Sponsored by
The Affiliated Ganzhou Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for 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) results
  • Subject is 18-75 yrs of age
  • Subject has a single stone < 3 cm in size, or multiple stones < 3 cm in cumulative size
  • Subject has a serum creatinine level within the normal range for the study center

Exclusion Criteria:

  • The patient who do not agree with the intention of the clinical study.
  • Subject needs bilateral procedures within one-stage ureteroscopy
  • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria
  • Subject has been diagnosed with a urethral stricture or bladder neck contracture
  • 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 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

    SF-URS with automatic control of RPP

    conventional F-URS

    Arm Description

    Participants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring).

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

    Outcomes

    Primary Outcome Measures

    stone-free rate
    Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%

    Secondary Outcome Measures

    stone-free rate
    Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%
    Complication rates
    Number of participants undergo novel or conventional F-URS surgeries suffer complications associated with the surgery (i.e. pain(NRS≥4), hematuria, T≥38℃, serum white blood cell≥12×〖10〗^9/L ,serum white blood cell<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%

    Full Information

    First Posted
    April 7, 2016
    Last Updated
    April 11, 2016
    Sponsor
    The Affiliated Ganzhou Hospital of Nanchang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02734914
    Brief Title
    Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure
    Official Title
    Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Affiliated Ganzhou Hospital of Nanchang University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.
    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, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy. Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure 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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SF-URS with automatic control of RPP
    Arm Type
    Experimental
    Arm Description
    Participants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring).
    Arm Title
    conventional F-URS
    Arm Type
    Active Comparator
    Arm Description
    Participants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope.
    Intervention Type
    Device
    Intervention Name(s)
    SF-URS with automatic control of RPP
    Intervention Description
    A new F-URS monitoring and control of RPP using intelligent pressure control device
    Intervention Type
    Device
    Intervention Name(s)
    conventional F-URS
    Intervention Description
    Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.
    Primary Outcome Measure Information:
    Title
    stone-free rate
    Description
    Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%
    Time Frame
    4 weeks post-operatively
    Secondary Outcome Measure Information:
    Title
    stone-free rate
    Description
    Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%
    Time Frame
    One day post-operatively
    Title
    Complication rates
    Description
    Number of participants undergo novel or conventional F-URS surgeries suffer complications associated with the surgery (i.e. pain(NRS≥4), hematuria, T≥38℃, serum white blood cell≥12×〖10〗^9/L ,serum white blood cell<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%
    Time Frame
    Within 4 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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) results Subject is 18-75 yrs of age Subject has a single stone < 3 cm in size, or multiple stones < 3 cm in cumulative size Subject has a serum creatinine level within the normal range for the study center Exclusion Criteria: The patient who do not agree with the intention of the clinical study. Subject needs bilateral procedures within one-stage ureteroscopy Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria Subject has been diagnosed with a urethral stricture or bladder neck contracture 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 been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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