NCT05195580

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

October 7, 2021

Last Update Submit

September 29, 2025

Conditions

Spinal FusionSpinal StenosisScoliosisSpondylolisthesis

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 ScannerDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 bony posterior spine anatomy for localization as standard of care.
  • Clinically planned for spine surgery.
  • Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study.

You may not qualify if:

  • Language problems that would prevent from properly understanding instructions.
  • Requirement of an interpreter.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. David's Round Rock Medical Center

Round Rock, Texas, 78681, 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: 26883549BACKGROUND

  • 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: 26590631BACKGROUND

  • 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: 17046629BACKGROUND

  • 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: 16289612BACKGROUND

  • 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

MeSH Terms

Conditions

Spinal StenosisScoliosisSpondylolisthesis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpinal CurvaturesSpondylolysisSpondylosis

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

October 7, 2021

First Posted

January 19, 2022

Study Start

August 31, 2021

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

US(1)