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Spine Registration Using 3D Scanning - Arise

A

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Status

Terminated

Conditions

Spondylolisthesis
Scoliosis
Spinal Fusion
Sciatica

Treatments

Device: Optical 3D Scanner

Study type

Observational

Funder types

Industry

Identifiers

NCT05195593
Spine - 001

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
  2. Have had a CT scan performed prior to the procedure.
  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.

Exclusion criteria

  1. Language problems that would prevent from properly understanding instructions.
  2. Patients less than 18 years of age.
  3. Requirement of an interpreter.
  4. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
  5. Special populations: pregnant women, prisoners.
  6. Minimally invasive spine surgery that does not expose the necessary bone/s.
  7. Spine surgery without posterior exposure.

Trial contacts and locations

1

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Central trial contact

Aaron Bernstein, PhD; Kelly Van Schouwen, MS, ACRP-CP

Data sourced from clinicaltrials.gov

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