DynaCT Imaging in EVAR: Comparing Clinical Benefit of Dyn... | NCT00264862

Studies
DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard.

NCT00264862

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Abdominal Aortic Aneurysm

Interventions

DynaCT

Countries

Norway

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

Feb 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

Dec 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Dec 12, 2005

First Submission Date that Met QC Criteria

Dec 12, 2005

First Posted Date

Dec 13, 2005Estimated

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

Feb 27, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Name	Class
St. Olavs Hospital	OTHER

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

The aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.

Detailed Description

The study will compare images from the new modality (DynaCT) with the present modality (Multi detectorCT). We make three different set of images from each modality.

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

20Actual

Name	Type	Description	Arm Group Labels	Other Names
DynaCT	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence og clinical benefit of new imaging functionality.		3 days (pluss or minus 3 days).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 65,
Satisfactory renal function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kari R Eide, MS	NTNU/St.Olavs Hospital	Principal Investigator
Olav Haraldseth, PhD MD	National Taiwan Normal University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hosptial		Trondheim		7006	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19010697	Result	Eide KR, Odegard A, Myhre HO, Lydersen S, Hatlinghus S, Haraldseth O. DynaCT during EVAR--a comparison with multidetector CT. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):23-30. doi: 10.1016/j.ejvs.2008.09.017. Epub 2008 Nov 17.

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases