Deformity of SpineNCT02418923
HemoSonics-UVA Spinal Surgery
An observational study of Deformity of Spine, run by University of Virginia at 1 site in United States.
Trial summary
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deformity of Spine
- What is being tested?
- Procedure: Blood specimen collection
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Aug 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants for this study will be recruited at the University of Virginia Medical Center. The subject population will be representative of the local racial and ethnic population.
Who may be able to join
- • Subject is scheduled for major deformity correction spine surgery
- Subject is older than 18 years
- Subject is willing to participate and he/she has signed a consent form
Who cannot join
- • Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
- Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
- Subjects with history of active liver disease
- Subjects affected by Factor V Leiden mutation
- Subjects affected by von Willebrand disease
- Subjects with an history of thrombotic disease (more than one DVT)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: HemoSonics-UVA Spinal Surgery Clinical Study Protocol
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.
Read the detailed description
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.
Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology
- Conditions
- Deformity of Spine
- Being tested
- Procedure: Blood specimen collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Blood specimen collectionOther
Blood specimen collection
What is being measured
The primary outcome is the main question the study is designed to answer.
assay inter-instrument variability
Demonstrate assay inter-instrument variability below 15%
Measured: 1 day
Establish normal ranges
Establish normal ranges
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity of SpineStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- HemoSonics LLC
- Responsible party
- Principal investigator, Bhiken I. Naik, MD, University of Virginia
- Investigators
- Bhiken Naik, MD, Principal investigator, UVA Anethesiology Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418923
- Sponsor's protocol ID
- 17942
- Status last verified
- May 2016
- First submitted
- 13 Apr 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HemoSonics-UVA Spinal Surgery Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT02418923
- Acronym / sponsor ID
- 17942
- Conditions
- Deformity of Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- HemoSonics LLC
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Apr 2015 (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.
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.
Detailed description
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.
Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for this study will be recruited at the University of Virginia Medical Center. The subject population will be representative of the local racial and ethnic population.
Key inclusion criteria (3 listed)
- • Subject is scheduled for major deformity correction spine surgery
Key exclusion criteria (8 listed)
- • Subject is unable to provide written 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 |
|---|---|---|
| Procedure: Blood specimen collectionBlood specimen collection | Other | – |
Primary outcome
assay inter-instrument variability
Time frame: 1 day
Demonstrate assay inter-instrument variability below 15%
Establish normal ranges
Time frame: 1 day
Establish normal ranges
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 May 2016.
- Individual participant dataSharing planned: No
Related trials for Deformity of Spine
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
ASD, Scoliosis Idiopathic Adolescent
Active, not recruitingObservational study
Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis
Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
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.
Bhiken Naik, MD principal investigator
UVA Anethesiology Faculty
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 Deformity of Spine, run by University of Virginia 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 8 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 May 2016. 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?
assay inter-instrument variability (time frame: 1 day). The study lists 2 primary outcomes in all. 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 May 2016.