Spine SurgeryNCT05269836
Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area
An observational study of Spine Surgery and Surgery, run by Surgify Medical Oy at 1 site in Finland.
Trial summary
Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spine Surgery, Surgery
- What is being tested?
- Surgify Safety Burr
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteFinland
- Study dates
- 14 Mar 2022to 17 Nov 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according to other inclusion and exclusion criteria.
Who may be able to join
- Disease of the spine or head requiring surgery with bone removal
- Ability to understand the purpose and risks of the study and to give written informed consent
- Age 18-70 years
Who cannot join
- Previous surgery on the same area
- Abnormalities of bone tissue
- Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation)
- Allergy or hypersensitivity to medical-grade stainless steel or any of alloying components
- Problems with blood clotting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.
Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.
Read the detailed description
Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.
- Conditions
- Spine Surgery, Surgery
- Being tested
- Surgify Safety Burr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgify Safety BurrDevice
Use of Surgify Safety Burr in hard tissue cutting, head and spine area
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate usability of SSB
Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon.
Measured: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
To evaluate safety of SSB
AE reporting
Measured: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
Secondary outcomes (2)
To evaluate effectiveness of SSB
Using video material from operations, microphone recording of the surgeon commentary during drilling
Measured: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
To evaluate beneficiality of SSB
Questionnaires to surgeon
Measured: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start14 Mar 2022
- Primary completion13 Oct 2022
- Study completion17 Nov 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surgify Medical Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Nuutti Vartiainen, Surgify Medical Oy
- Investigators
- Nuutti Vartiainen, MD, PhD, Principal investigator, HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269836
- Sponsor's protocol ID
- Surgify2021
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.
- ClinicalTrials.gov ID
- NCT05269836
- Acronym / sponsor ID
- Surgify2021
- Conditions
- Spine Surgery, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Surgify Medical OyIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 8 Mar 2022 (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.
Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.
Detailed description
Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according to other inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Disease of the spine or head requiring surgery with bone removal
- Ability to understand the purpose and risks of the study and to give written informed consent
- Age 18-70 years
Key exclusion criteria (5 listed)
- Previous surgery on the same area
- Abnormalities of bone tissue
- Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation)
- Allergy or hypersensitivity to medical-grade stainless steel or any of 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 |
|---|---|---|
| Surgify Safety BurrUse of Surgify Safety Burr in hard tissue cutting, head and spine area | Device | – |
Primary outcome
To evaluate usability of SSB
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon.
To evaluate safety of SSB
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
AE reporting
2 secondary outcomes
To evaluate effectiveness of SSB
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
To evaluate beneficiality of SSB
Time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week
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 30 Nov 2022.
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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.
Nuutti Vartiainen, MD, PhD principal investigator
HUS
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 Spine Surgery and Surgery, run by Surgify Medical Oy at 1 site in Finland.
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 5 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 30 Nov 2022. 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 Finland. 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?
To evaluate usability of SSB (time frame: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.). 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 30 Nov 2022.