NCT03087812

Brief Summary

This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

November 19, 2015

Last Update Submit

April 9, 2018

Conditions

Kidney Stones

Keywords

Microbiological burdenkidneystonedurability of flexible endoscopes

Outcome Measures

Primary Outcomes (1)

  • Microbiological load

    To evaluate the pre-operative microbiological load of the tip and the working channel of the most common used flexible ureteroscopes, after high level disinfection

    2 years

Secondary Outcomes (2)

  • Durability

    2 years

  • Factors affecting durability

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population compromises those patients of over eighteen years old diagnosed to undergo a ureterorenoscopy (diagnostic or therapeutic) with a flexible ureterorenoscope.

You may qualify if:

  • Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
  • over 18 years
  • has signed informed consent
  • the patient is being treated with the designated flexible ureterorenoscope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMC University Hospital

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Kidney CalculiCalculi

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jean de la Rosette, MD, PhD

    Clinical Research Office of the Endourological Society

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

March 23, 2017

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

NL(1)