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OpenTrials
Enrolling by Invitation

NCT Number: NCT06267248

Spine Registration Using 3D-Scanning

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.

Enrolling by Invitation

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mass General Bringham, Hale Building for Transformative Medicine

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Optical 3D Scanner

Device

An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.

Primary outcomes

  1. Spine Registration

    Time frame: Throughout the surgical procedure

    Closely match the Advanced Scanners optical scan of the partially exposed surface of the patient vertebra to the corresponding patient's preoperative MRI and/or CT scan, thereby learning the position of the rest of the vertebra. This endpoint includes registration of the relevant preoperative MRI or CT scan portion to the portion scanned by Advanced Scanners.

Secondary outcomes

  1. Vertebral Shift Measurement

    Time frame: Throughout the surgical procedure

    Use the intraoperative x-ray (typically O-arm) measurements taken at various times in the procedure to validate the capability of our scanner to determine relative shifts between vertebra as a function of time.

  2. Determination Of Bony Exposure Requirements

    Time frame: Throughout the surgical procedure

    Measure the area of the exposed vertebra of registered adjacent segments. Bone regions will be identified in the scan mesh, segmented from the rest of the scan, and their areas determined directly from that surface region by integrating the area of the relevant mesh faces, in units of square millimeters or square centimeters.

Sponsors and collaborators

Lead sponsor

Advanced Scanners Inc.

Industry

Registry information

Official study title

Pre-pilot Study of Spine Registration Using 3D Scanning

Acronym: BWH

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 20, 2024
Registry last updated
Oct 6, 2025

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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