Clinical trial NCT06267248: Spine Registration Using 3D-Scanning
Official title: Pre-pilot Study of Spine Registration Using 3D Scanning
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spine Surgery
Lead sponsor: Advanced Scanners Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Spine Registration
timeFrame: Throughout the surgical procedure
Secondary outcomes:
measure: Vertebral Shift Measurement
timeFrame: Throughout the surgical procedure
measure: Determination Of Bony Exposure Requirements
timeFrame: Throughout the surgical procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Bringham, Hale Building for Transformative Medicine
state: Massachusetts
Study officials:
affiliation: Advanced Scanners Inc.
name: Aaron Bernstein, PhD
role: STUDY_DIRECTOR
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