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

Surgify Medical

Status: Completed

Conditions: Spine Surgery; Surgery

Treatments: Device: Surgify Safety Burr

Study type: Observational

Funder types: Industry

Identifiers

NCT05269836

Surgify2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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