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Completed

NCT Number: NCT05269836

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.

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Key information

Conditions

Spine Surgery Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HUS,Töölö hospital

Helsinki, 00290, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Surgify Safety Burr

Device

Use of Surgify Safety Burr in hard tissue cutting, head and spine area

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

    Using video material from operations, microphone recording of the surgeon commentary during drilling

  2. 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

    Questionnaires to surgeon

Sponsors and collaborators

Lead sponsor

Surgify Medical Oy

Industry

Registry information

Official study title

Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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