NCT01542593

Brief Summary

Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length. Measurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

3.1 years

First QC Date

February 16, 2012

Last Update Submit

April 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization

    1 year

Study Arms (1)

Ureteral catheterization

EXPERIMENTAL

During a planned procedure involving ureteroscopy or ureteral stenting, ureteral catheterization will be performed for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery).

Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR

Interventions

During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery).

Also known as: Cook Urological Inc. open end ureteral catheter 5FR, Karl Storz cystoscope 19-22F
Ureteral catheterization

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing planned procedure involving ureteroscopy or ureteral stenting
  • Abdominal CT scan performed within 6 months prior to intervention

You may not qualify if:

  • Known iodine sensitivity
  • Patients with fever or hemodynamic instability planned for urgent operation
  • Severe immune compromized patients
  • Severe thrombocytopenia \< 50,000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Ureteral CalculiHydronephrosisUreteral Obstruction

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsKidney Diseases

Study Officials

  • Yuval Freifeld, Dr.

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident , Urology Department, principal investigator, Medical doctor

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations