Bone InjuriesNCT01601782
Impact of Volume Imaging Using Diagnostic Ultrasound
A study testing Ultrasound Scan and Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). in people with Bone Injuries and Muscle Injuries, run by University of Michigan at 1 site in United States.
Trial summary
Determine if volume imaging can diagnose bone, ligament, muscle injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Injuries, Muscle Injuries, Tendon Injuries
- What is being tested?
- Ultrasound Scan and Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.
Who cannot join
- Unable to lie flat on ultrasound table.
- Subjects under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Volume Imaging With Ultrasound
Determine if volume imaging can diagnose bone, ligament, muscle injuries.
Read the detailed description
The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.
- Conditions
- Bone Injuries, Muscle Injuries, Tendon Injuries
- Being tested
- Ultrasound Scan, Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScanProcedure or surgery
Also called Volumetric Ultrasound, 3D Ultrasound Imaging, Volume Imaging
Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician.
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).Device
The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries.
| Study group | Role | What they receive |
|---|---|---|
| Volume Imaging scan | Experimental | New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9. Receives: Procedure: Ultrasound Scan; Device: Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging
Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.
Measured: Up to 13 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMay 2010
Why it stopped: It was determined that the volume imaging was not working.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone InjuriesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Jacobson, University of Michigan
- Investigators
- Jon Jacobson, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601782
- Sponsor's protocol ID
- HUM00030780
- Status last verified
- Dec 2017
- First submitted
- 1 May 2012
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Volume Imaging With Ultrasound
- ClinicalTrials.gov ID
- NCT01601782
- Acronym / sponsor ID
- HUM00030780
- Conditions
- Bone Injuries, Muscle Injuries, Tendon Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was determined that the volume imaging was not working.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 19 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if volume imaging can diagnose bone, ligament, muscle injuries.
Detailed description
The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volume Imaging scan | Experimental | Procedure: Ultrasound Scan, Device: Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.
Key exclusion criteria (2 listed)
- Unable to lie flat on ultrasound table.
- Subjects under 18 years of age
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 |
|---|---|---|
| Ultrasound ScanAlso: Volumetric Ultrasound, 3D Ultrasound Imaging, Volume ImagingSubject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician. | Procedure or surgery | Volume Imaging scan |
| Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries. | Device | Volume Imaging scan |
Primary outcome
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging
Time frame: Up to 13 minutes
Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon Jacobson, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Scan and Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). in people with Bone Injuries and Muscle Injuries, run by University of Michigan 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 2 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: stopped early, as of the sponsor's last update on 19 Jan 2018. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging (time frame: Up to 13 minutes). 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 19 Jan 2018.