3D Body Surface Modeling for Scoliosis Monitoring

RECRUITING

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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.

Conditions:

Adolescent Idiopathic Scoliosis

Study Start (Actual) 2020-08-26

Primary Completion (Estimated) 2030-01-01

Study Completion (Estimated) 2030-01-01

Enrollment (Estimated) 13

Study Type OBSERVATIONAL

Phase N/A

Locations:

📍 Palo Alto, California, United States

Eligibility Criteria

Description

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)

Ages Eligible for Study: 10 Years to 18 Years (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-01-14
First Submitted that Met QC Criteria2023-01-14
First Posted2023-01-26

Study Record Updates

Last Update Submitted that Met QC Criteria2023-12-22
Last Update Posted2024-01-02
Last Verified2023-12