Other Conditions That May Be A Focus of Clinical AttentionNCT01801514
Applications of Dual-Energy Computed Tomography
A study testing Computed Tomography scan in people with Other Conditions That May Be A Focus of Clinical Attention, run by Philips Healthcare at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Other Conditions That May Be A Focus of Clinical Attention
- What is being tested?
- Computed Tomography scan
- Type of treatment
- Medical device
- How many people
- 337 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Mar 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or potentially pregnant female subjects
- Subjects who are not able or not willing to give written Informed Consent without a caregiver consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Computed Tomography scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography scanDevice
Routine Computed Tomography scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability of producing dual energy computed tomography imaging and dual energy applications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Conditions That May Be A Focus of Clinical AttentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Sosna, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801514
- Sponsor's protocol ID
- iCT DL
- Status last verified
- Nov 2014
- First submitted
- 27 Feb 2013
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of Dual-Energy Computed Tomography
- ClinicalTrials.gov ID
- NCT01801514
- Acronym / sponsor ID
- iCT DL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Feb 2013 (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 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or potentially pregnant female subjects
- Subjects who are not able or not willing to give written Informed Consent without a caregiver 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 |
|---|---|---|
| Computed Tomography scanRoutine Computed Tomography scan | Device | – |
Primary outcome
Capability of producing dual energy computed tomography imaging and dual energy applications
Time frame: 6 months
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 11 Nov 2014.
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.
Jacob Sosna, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography scan in people with Other Conditions That May Be A Focus of Clinical Attention, run by Philips Healthcare at 1 site in Israel.
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 2 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 11 Nov 2014. 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 Israel. 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?
Capability of producing dual energy computed tomography imaging and dual energy applications (time frame: 6 months). 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 11 Nov 2014.