Spine SurgeryNCT06827795
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
A study testing A burr used in spine surgery in people with Spine Surgery, run by Surgify Medical Oy at 1 site in United States.
Trial summary
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr). Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- A burr used in spine surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease of the spine requiring surgery with bone removal
- Ability to understand the purpose and risks of the study and to give written informed consent
- Age 21-85 years
Who cannot join
- Abnormalities of bone tissue
- Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
- Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
- Problems with blood clotting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Shore University Hospital
New York, New York, 11030
Thanuja Amirthalingam, Study coordinator, 516-382-3666, tamirthalingam@northwell.edu
Sheng-fu Larry Lo, Neurosurgeon
About this study
The purpose of this research study is to:
test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).
This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The target is to enroll 30 participants in this study.
- Conditions
- Spine Surgery
- Being tested
- A burr used in spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A burr used in spine surgeryDevice
A burr used in spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgify Halo | Other | Not described Receives: Device: A burr used in spine surgery |
| State of art Rosen burr | Other | Not described Receives: Device: A burr used in spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)
Measured: From enrollment to the end of the surgery until the end of the stay in the recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start19 Feb 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surgify Medical Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North Shore University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827795
- Sponsor's protocol ID
- Pro00079896
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
- ClinicalTrials.gov ID
- NCT06827795
- Acronym / sponsor ID
- Pro00079896
- Conditions
- Spine Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Surgify Medical OyIndustry (pharma, biotech, devices)
- Collaborators
- North Shore University Hospital
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2025 (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.
The purpose of this research study is to:
test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).
This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The target is to enroll 30 participants in this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgify Halo | Other | Device: A burr used in spine surgery |
| State of art Rosen burr | Other | Device: A burr used in spine surgery |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Disease of the spine requiring surgery with bone removal
Key exclusion criteria (4 listed)
- Abnormalities of bone tissue
- Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
- Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
- Problems with blood clotting
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 |
|---|---|---|
| A burr used in spine surgeryA burr used in spine surgery | Device | State of art Rosen burr, Surgify Halo |
Primary outcome
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
Time frame: From enrollment to the end of the surgery until the end of the stay in the recovery room.
Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Spine Surgery
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Recruiting
Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring
Spine Surgery, Intraoperative Neurophysiological Monitoring
Enrolling by invitation
SpinePal Open Pilot
Spine Surgery
Recruiting
Surgical Recovery Support Pillow for Spine Surgeries
Spine Surgery Complications, Infection
RecruitingObservational study
ACSS Approach on Dysphagia
Anterior Cervical Spine Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A burr used in spine surgery in people with Spine Surgery, run by Surgify Medical Oy 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery (time frame: From enrollment to the end of the surgery until the end of the stay in the recovery room.). 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 30 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.