Spine Registration Using 3D-Scanning

NCT06267248 | Enrolling By Invitation FDA Device

• 1 other identifier: T05100
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Spine Registration

  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.

  Throughout the surgical procedure

Secondary Outcomes (2)

• Vertebral Shift Measurement

  Throughout the surgical procedure

• Determination Of Bony Exposure Requirements

  Throughout the surgical procedure

Interventions

Optical 3D Scanner DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be invited to participate from the Principal Investigator's clinic population. All subjects will be identified as requiring a spine surgery that meets the eligibility requirements.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Scanners Inc.: lead

Study Sites (1)

Mass General Bringham, Hale Building for Transformative Medicine

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• Arlt F, Chalopin C, Muns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007/s00701-016-2738-z. Epub 2016 Feb 16.

  PMID: 26883549 BACKGROUND

• Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).

  BACKGROUND

• Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016/j.bjps.2015.10.011. Epub 2015 Oct 22.

  PMID: 26590631 BACKGROUND

• Kovacs L, Zimmermann A, Brockmann G, Guhring M, Baurecht H, Papadopulos NA, Schwenzer-Zimmerer K, Sader R, Biemer E, Zeilhofer HF. Three-dimensional recording of the human face with a 3D laser scanner. J Plast Reconstr Aesthet Surg. 2006;59(11):1193-202. doi: 10.1016/j.bjps.2005.10.025. Epub 2006 Mar 9.

  PMID: 17046629 BACKGROUND

• Park HK, Chung JW, Kho HS. Use of hand-held laser scanning in the assessment of craniometry. Forensic Sci Int. 2006 Jul 13;160(2-3):200-6. doi: 10.1016/j.forsciint.2005.10.007. Epub 2005 Nov 9.

  PMID: 16289612 BACKGROUND

• Zhang, D., Lu, G., Li, W., Zhang, L. & Luo, N. Palmprint Recognition Using 3-D Information. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 39, 505-519 (2009).

  BACKGROUND

Study Officials

• Aaron Bernstein, PhD

  Advanced Scanners Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)