3D Body Surface Modeling for Scoliosis Monitoring

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Trial ID: NCT05697939

Purpose

This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.

Official Title

Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - Ages 10 and 18 years old

   - Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis

Exclusion Criteria:

   - Scoliosis caused by another condition (e.g., secondary scoliosis)

   - Parents/guardians unable to consent

   - English is not the primary language (to avoid miscommunication)

Intervention(s):

diagnostic test: NSite 3D Scanning

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kali R Tileston, MD
(650) 497-8891