NCT01318772

Brief Summary

The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

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

December 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
Last Updated

March 18, 2011

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

March 17, 2011

Last Update Submit

March 17, 2011

Conditions

Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.

Outcome Measures

Primary Outcomes (1)

  • Collection of representative images

    Collect 30 to 60 represenative images to support pre-market submission.

    Estimated completion 4 weeks after start of the study

Study Arms (1)

Fluoroscopy and Angiography Procedure

Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician.

Device: Radiography and Fluoroscopy Imaging System

Interventions

Radiography and Fluoroscopy Imaging SystemDEVICE

KALARE (DREX-KL80) is a new high resolution digital system designed for digital spot imaging, with the primary goal to address R/F and DSA clinical applications and produce images in a digital format. The system includes a new digital camera and a new image processor.

Also known as: KALARE (DREX-KL80)
Fluoroscopy and Angiography Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patient 18 years and older

You may qualify if:

  • Male and female patient 18 years and older
  • Not pregnant
  • Not a safety risk patient

You may not qualify if:

  • Male and female patient under 18 years old
  • Pregnant subjects
  • High safety risk subjects
  • Subjects and/or Legal Guardian Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SDMI

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Interventions

Radiography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mark Winkler, M.D.

    Stienberg Diagnostic Meidcal Imaging (SDMI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 18, 2011

Record last verified: 2011-03

Locations

US(1)