Spine FusionNCT04682418
Pedicle Screw Placement With XVS
A study testing xvision Spine sytem in people with Spine Fusion, run by Augmedics at 3 sites in Israel.
Trial summary
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Fusion
- What is being tested?
- xvision Spine sytem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesIsrael
- Study dates
- 20 May 2018to 7 Jul 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 - 80 yrs.
- Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
- Subjects requiring a posterior approach surgical procedure.
- Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.
Who cannot join
- Subjects with severe Osteoporosis (T score <-3.5)
- Subjects with kyphosis at the operated area (≥ stage 3)
- Subjects with Spondylolisthesis Grade III and above.
- Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
- Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
- Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
Show all 13Show fewer
- Subjects with spinal cord abnormalities with any neurologic symptoms or signs
- Paraplegia.
- Pedicle fracture documented before or during surgery.
- Women pregnant or lactating
- Subjects requiring anterior release or instrumentation.
- Subjects who are unwilling to sign written informed consent and assent to participate in the study.
- -
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Haemek MC
Afula
Sheeba Medical Center
Tel Litwinsky, 52621
Asaf Harofeh
Tzrifin, 70300
About this study
Official title: Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.
Read more
Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.
Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.
Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure
- Conditions
- Spine Fusion
- Being tested
- xvision Spine sytem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xvision Spine sytemDevice
Also called XVS
pedicle screw placement will be performed using the XVS navigation system
| Study group | Role | What they receive |
|---|---|---|
| xvision Spine | Experimental | Not described Receives: Device: xvision Spine sytem |
What is being measured
The primary outcome is the main question the study is designed to answer.
accurate placement of pedicle screws
accurate placement will be evaluated using Gertzbein and Robbins
Measured: through study completion , an average of 6 months.
Secondary outcomes (1)
usability and ease of use of the system: questionnaire
usability will be evaluated by questionnaire
Measured: The surgeon fills a questionnaire after the surgery, within 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start20 May 2018
- Primary completion16 Mar 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augmedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682418
- Sponsor's protocol ID
- DHF-VAP-002
- Status last verified
- Dec 2020
- First submitted
- 5 Apr 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System
- ClinicalTrials.gov ID
- NCT04682418
- Acronym / sponsor ID
- DHF-VAP-002
- Conditions
- Spine Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AugmedicsIndustry (pharma, biotech, devices)
- Study start
- 20 May 2018 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- 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.
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.
Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.
Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.
Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| xvision Spine | Experimental | Device: xvision Spine sytem |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18 - 80 yrs.
- Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
- Subjects requiring a posterior approach surgical procedure.
- Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.
Key exclusion criteria (13 listed)
- Subjects with severe Osteoporosis (T score <-3.5)
- Subjects with kyphosis at the operated area (≥ stage 3)
- Subjects with Spondylolisthesis Grade III and above.
- Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
- Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
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 |
|---|---|---|
| xvision Spine sytemAlso: XVSpedicle screw placement will be performed using the XVS navigation system | Device | xvision Spine |
Primary outcome
accurate placement of pedicle screws
Time frame: through study completion , an average of 6 months.
accurate placement will be evaluated using Gertzbein and Robbins
1 secondary outcome
usability and ease of use of the system: questionnaire
Time frame: The surgeon fills a questionnaire after the surgery, within 7 days.
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 24 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xvision Spine sytem in people with Spine Fusion, run by Augmedics at 3 sites 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 4 inclusion and 13 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
accurate placement of pedicle screws (time frame: through study completion , an average of 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 24 Aug 2021.