Study to Look for Artifact on Computed Tomography (CT) Re... | NCT01187745

Studies
Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones

NCT01187745

Sponsor

Ottawa Hospital Research Institute

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

Kidney Stones

Interventions

CT Scan followed by ultrasound

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Aug 23, 2010

First Submission Date that Met QC Criteria

Aug 23, 2010

First Posted Date

Aug 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT) scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate kidneys for suspected renal stones.

Detailed Description

All patients aged 18 years of age and over who are undergoing a renal stone protocol for evaluation of flank pain will be included.

Pregnant patients will not be included.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
suspect kidney stones		Patients presenting with flank abdominal pain	Other: CT Scan followed by ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT Scan followed by ultrasound	Other	A limited U/S is performed after the CT scan which is ordered by the Emergency Department physician.	suspect kidney stones

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The detection of kidney stones on ultrasound compared to CT.		One year

Secondary Outcomes

Measure	Description	Time Frame
Presence of hydronephrosis, a sign of obstruction of the urinary tract, will also be detected.		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult, able to consent, flank pain

Exclusion Criteria:

Pregnant, unable to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with flank pain in the emergency department, suspected to have kidney stones.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ania Kielar, MD FRCPC	Ottawa Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ottawa Hospital Civic and General Campuses		Ottawa	Ontario	K1Y 4E9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided