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Enrolling by invitationNCT06267248BWHUpdated Oct 6, 2025

Spine Registration Using 3D-Scanning

An observational study in Spine Surgery, sponsored by Advanced Scanners Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by Advanced Scanners Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spine Surgery
03

In context

Lead sponsor

Advanced Scanners Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  1. Patients that require exposure of posterior bony anatomy for visualization as standard of care.
  2. 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.
  3. Clinically planned for spine surgery.
  4. Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.
  5. 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

Exclusion Criteria:

  1. Language problems that would prevent from properly understanding instructions in any language.
  2. Patients less than 18 years of age or older than 80 years of age
  3. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
  4. Special populations: pregnant women, prisoners.
  5. Minimally invasive spine surgery that does not expose the necessary bone/s.
  6. Spine surgery without posterior exposure.
  7. Patients considered high risk for anesthesia, as determined by operative surgeon
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • DeviceOptical 3D Scanner

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

06

What researchers measure

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.

    Time frame: Throughout the surgical procedure

Secondary outcomes

  1. Vertebral Shift Measurement

    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.

    Time frame: Throughout the surgical procedure

  2. Determination Of Bony Exposure Requirements

    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.

    Time frame: Throughout the surgical procedure

07

Study locations

1 site
  • Mass General Bringham, Hale Building for Transformative Medicine
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • 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. PubMed 26883549 ↗
  • Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).
  • 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. PubMed 26590631 ↗
  • 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. PubMed 17046629 ↗
  • 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. PubMed 16289612 ↗
  • 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).

Individual participant data

Plan to share: Undecided — If data is shared, it will be anonymized.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06267248
Lead sponsor
Advanced Scanners Inc.
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Nov 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Nov 2028 (estimated)
Last update
Oct 6, 2025

Study contacts

Aaron Bernstein, PhD
study director · Advanced Scanners Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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