Spine Registration Using 3D-Scanning (BWH)

A

Advanced Scanners

Status

Invitation-only

Conditions

Spine Surgery

Treatments

Device: Optical 3D Scanner

Study type

Observational

Funder types

Industry

Identifiers

NCT06267248
T05100

Details and patient eligibility

About

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients that require exposure of posterior bony anatomy for visualization as standard of care.
  • Patients will have had a CT scan performed prior to the procedure as standard of care, or is expected to have a CT scan intraoperatively as standard of care.
  • Clinically planned for spine surgery.
  • Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.
  • Patients who do not speak English will be allowed to participate, with the expectation that the site will provide interpreter services to help with the consent process.

Exclusion criteria

  • Language problems that would prevent from properly understanding instructions in any language.
  • Patients less than 18 years of age or older than 80 years of age
  • Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
  • Special populations: pregnant women, prisoners.
  • Minimally invasive spine surgery that does not expose the necessary bone/s.
  • Spine surgery without posterior exposure.
  • Patients considered high risk for anesthesia, as determined by operative surgeon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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