NCT02734914

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

April 7, 2016

Last Update Submit

April 11, 2016

Conditions

Renal Calculi

Outcome Measures

Primary Outcomes (1)

  • stone-free rate

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

    4 weeks post-operatively

Secondary Outcomes (2)

  • stone-free rate

    One day post-operatively

  • Complication rates

    Within 4 weeks after surgery

Study Arms (2)

SF-URS with automatic control of RPP

EXPERIMENTAL

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).

Device: SF-URS with automatic control of RPP

conventional F-URS

ACTIVE COMPARATOR

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

Device: conventional F-URS

Interventions

SF-URS with automatic control of RPPDEVICE

A new F-URS monitoring and control of RPP using intelligent pressure control device

SF-URS with automatic control of RPP
conventional F-URSDEVICE

Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.

conventional F-URS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 12, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

April 12, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share