NCT01801514

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

February 27, 2013

Last Update Submit

November 10, 2014

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Outcome Measures

Primary Outcomes (1)

  • Capability of producing dual energy computed tomography imaging and dual energy applications

    6 months

Interventions

Computed Tomography scanDEVICE

Routine Computed Tomography scan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Jacob Sosna, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

February 28, 2013

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

IL(1)