NCT05269836

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

January 25, 2022

Last Update Submit

November 29, 2022

Conditions

Spine SurgerySurgery

Outcome Measures

Primary Outcomes (2)

  • To evaluate usability of SSB

    Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon.

    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

    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

    Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.

  • To evaluate beneficiality of SSB

    Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week

Interventions

Surgify Safety BurrDEVICE

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any 18 to 70 -year old patient scheduled to back/head operation can be recruited according to other inclusion and exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUS,Töölö hospital

Helsinki, 00290, Finland

Location

Study Officials

  • Nuutti Vartiainen, MD, PhD

    HUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HUS, Töölö Hospital

Study Record Dates

First Submitted

January 25, 2022

First Posted

March 8, 2022

Study Start

March 14, 2022

Primary Completion

October 13, 2022

Study Completion

November 17, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

FI(1)