Surgify Halo for Spinal Surgery

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Surgify Medical Oy

Disqualifiers: Previous surgery, Bone abnormalities, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: From enrollment to the end of the surgery until the end of the stay in the recovery room

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new device, Surgify Halo™, during spinal surgery. The researchers aim to determine if it performs better and causes less "chattering" than the standard drill bit used for bone removal. The trial seeks participants who need surgery involving bone removal in the spine or head and can understand the study's purpose. Individuals with a spine condition requiring surgery may find this trial suitable. As an unphased trial, participation offers a chance to contribute to innovative surgical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Surgify Halo device is safe for spinal surgery?

Research has shown that the Surgify Halo device is as safe as other surgical tools. The FDA has cleared it, indicating it passed key safety tests in the U.S., and it is also approved for use in Europe. Surgeons use this device to cut bone safely and accurately during surgeries, including spine operations. To date, there have been no reports of major safety problems, making it a reliable choice for surgical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Surgify Halo for spinal surgery because it offers a new way to make spine operations safer and potentially more effective. Unlike traditional surgical tools, which can risk damaging surrounding tissues, the Surgify Halo is designed to precisely target and remove bone while minimizing harm to nearby nerves and blood vessels. This innovative approach not only aims to reduce complications but also hopes to improve recovery times for patients. By focusing on precision and safety, the Surgify Halo could set a new standard in spinal surgery techniques.

What evidence suggests that the Surgify Halo device is effective for spinal surgery?

Research shows that the Surgify Halo™ device performs well in spine surgery. In this trial, participants will receive either the Surgify Halo™ or the state-of-the-art Rosen burr. One study found no soft-tissue injuries during surgeries using the Surgify Halo™, while traditional tools had a 29% injury rate. Successful surgeries at Helsinki University Hospital further demonstrate its safety and effectiveness. The device aims to make bone surgery safer and smarter, reducing risks like nerve damage. These findings support the potential effectiveness of the Surgify Halo™ in repeat spine surgeries. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing revision spine surgery. Participants should be eligible for the surgical procedure and have no conditions that would exclude them from using the Surgify Halo™ or Rosen Burr devices.

Inclusion Criteria

Ability to understand the purpose and risks of the study and to give written informed consent

I am between 21 and 85 years old.

I need surgery for my spine or head that involves removing bone.

Exclusion Criteria

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

I have had surgery in the same area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine surgery using either the Surgify Halo or the Rosen burr device

From enrollment to the end of the surgery until the end of the stay in the recovery room

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Surgify HaloTM

Trial Overview The study aims to compare a new medical device, Surgify Halo™, with the standard Rosen Burr in terms of usability and performance during spine surgery. It will specifically evaluate 'chattering' and cutting effectiveness.

How Is the Trial Designed?

Group I: Surgify Halo Experimental Treatment 1 Intervention

Group II: State of art Rosen burr Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Surgify Medical Oy

Lead Sponsor

Trials

2

Recruited

50+

North Shore University Hospital

Collaborator

Trials

15

Recruited

3,700+

Citations

1. surgifymedical.com surgifymedical.com/news/surgify-at-eans-2024

Surgify at EANS 2024 The aim of the study was to evaluate the safety, clinical performance, and effectiveness of Surgify Halo™. The observational study included 20 ...

2. surgifymedical.com surgifymedical.com/resources/clinical-studies

Clinical Studies In these tests soft-tissue injuries occurred in none (0%) of the performed surgeries with Surgify Halo™ and in 10 (29%) of the performed surgeries with ...

3. techfundingnews.com techfundingnews.com/no-more-nerve-damage-surgify-medical-closes-e7m-to-make-bone-surgery-safer-faster-and-smarter/

No more nerve damage? Surgify Medical closes €7M to ... The first successful surgeries using Surgify's Halo drill were performed at Helsinki University Hospital in October 2021. Head of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11969806/

The effectiveness and safety of staged halo-pelvic traction ... The overall complication rate during HPT was 16.4%, while surgery-related complications were 18.0%, with no permanent neurological deficits ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1040738325000577

Halo gravity traction and Temporary Internal Distraction Clinical studies report Cobb angle reductions of 30–80%, with low rates of neurologic complications when neuromonitoring and mean arterial ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232684.pdf

November 29, 2023 Surgify Medical Oy Sujith Shetty ... In addition, testing confirmed that the Surgify Halo device has an equivalent safety profile to the predicate device. Therefore, the ...

7. surgifymedical.com surgifymedical.com/home-us

Home US Surgify Halo™ is an FDA-cleared (510(k)) Class II medical device in the United States and a CE-marked medical device in the EU (Notified Body no. 0537). Patent ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06827795

Study Details | NCT06827795 | An Open, Parallel-group, ... The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in revision spine surgery test the level of " ...

9. surgifymedical.com surgifymedical.com/products/surgify-safety-burr

Surgify Halo™ Surgify Halo is a tissue-selective surgical drill for bone cutting that offers improved safety, precision, and speed in procedures on the cranium or spine.