TerminatedNot Applicable

Spine Registration Using 3D Scanning

Stopped: Low enrollment of subjects

United States2 participantsStarted 2021-08-31

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Spine Registration

Timeframe: Throughout the surgical procedure

Trial details

NCT IDNCT05195580

SponsorAdvanced Scanners Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11-02

View on ClinicalTrials.gov More Spinal Fusion trials