3D Body Surface Modeling for Scoliosis Monitoring

Running, not enrolling

Conditions studied: Adolescent Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT05697939

Run by

Stanford University

People needed

13

Starts

2020-08-26

Expected to finish

2030-01-01

Last updated by the study team

2026-06-08

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 10 and 18 years old
• Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis

You may not qualify if…

• Scoliosis caused by another condition (e.g., secondary scoliosis)
• Parents/guardians unable to consent
• English is not the primary language (to avoid miscommunication)

Where it is running

• Lucille Packard Children's Hospital and Clinics — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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