Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.NCT01318772
Clinical Image Evaluation for the DREX-KL80 Imaging System
An observational study of Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation., run by Toshiba America Medical Systems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.
- What is being tested?
- Radiography and Fluoroscopy Imaging System
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female patient 18 years and older
Who may be able to join
- Male and female patient 18 years and older
- Not pregnant
- Not a safety risk patient
Who cannot join
- Male and female patient under 18 years old
- Pregnant subjects
- High safety risk subjects
- Subjects and/or Legal Guardian Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor
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.
- Being tested
- Radiography and Fluoroscopy Imaging System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiography and Fluoroscopy Imaging SystemDevice
Also called KALARE (DREX-KL80)
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy and Angiography Procedure | Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician. Receives: Device: Radiography and Fluoroscopy Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of representative images
Collect 30 to 60 represenative images to support pre-market submission.
Measured: Estimated completion 4 weeks after start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toshiba America Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Winkler, M.D., Principal investigator, Stienberg Diagnostic Meidcal Imaging (SDMI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318772
- Sponsor's protocol ID
- KH-001
- Status last verified
- Mar 2011
- First submitted
- 17 Mar 2011
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor
- ClinicalTrials.gov ID
- NCT01318772
- Acronym / sponsor ID
- KH-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Toshiba America Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy and Angiography Procedure | – | Device: Radiography and Fluoroscopy Imaging SystemPatient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patient 18 years and older
Key inclusion criteria (3 listed)
- Male and female patient 18 years and older
- Not pregnant
- Not a safety risk patient
Key exclusion criteria (4 listed)
- Male and female patient under 18 years old
- Pregnant subjects
- High safety risk subjects
- Subjects and/or Legal Guardian Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiography and Fluoroscopy Imaging SystemAlso: KALARE (DREX-KL80)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. | Device | Fluoroscopy and Angiography Procedure |
Primary outcome
Collection of representative images
Time frame: Estimated completion 4 weeks after start of the study
Collect 30 to 60 represenative images to support pre-market submission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Winkler, M.D. principal investigator
Stienberg Diagnostic Meidcal Imaging (SDMI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation., run by Toshiba America Medical Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of representative images (time frame: Estimated completion 4 weeks after start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2011.