Applications of Dual-Energy Computed Tomography | NCT01801514

Studies
Applications of Dual-Energy Computed Tomography

NCT01801514

Sponsor

Philips Healthcare

Status

Completed

Last Update Posted

Nov 11, 2014Estimated

Enrollment

337Actual

Phase

Not Applicable

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Interventions

Computed Tomography scan

Countries

Israel

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

Nov 2014

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

Nov 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 27, 2013

First Submission Date that Met QC Criteria

Feb 27, 2013

First Posted Date

Feb 28, 2013Estimated

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

Nov 10, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of the study is to evaluate the feasibility of multilayer detection-based dual energy computed tomography scanner and to assess the added diagnostic value of dual energy applications

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

337Actual

Name	Type	Description	Arm Group Labels	Other Names
Computed Tomography scan	Device	Routine Computed Tomography scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Capability of producing dual energy computed tomography imaging and dual energy applications		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subject
Subjects with relative clinical findings indicative for CT examination. CT referral request approved by a physician is needed
Voluntary signed the Informed Consent Form

Exclusion Criteria:

Pregnant or potentially pregnant female subjects
Subjects who are not able or not willing to give written Informed Consent without a caregiver consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Sosna, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah-Hebrew University Medical Center		Jerusalem			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D014057	Tomography, X-Ray Computed

Ancestor Terms

ID	Term
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided