TerminatedNot Applicable

Spine Registration Using 3D Scanning - Arise

Stopped: Hospital is closing for an undetermined amount of time

United States1 participantsStarted 2022-01-05

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

Age range18 Years

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.
✓. Have had a CT scan performed prior to the procedure.
✓. 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.

Exclusion criteria

✕. Language problems that would prevent from properly understanding instructions.
✕. Patients less than 18 years of age.
✕. 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 IDNCT05195593

SponsorAdvanced Scanners Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Spinal Fusion trials