3D body surface modeling for monitoring scoliosis in adolescents
Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
This study is testing a new device to see if it can give consistent measurements of scoliosis in teenagers aged 10 to 18 when used by different people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 13 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05697939 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the NSite device's ability to provide consistent measurements of scoliosis in adolescents aged 10 to 18 years. A total of 13 patients will be scanned by three different users to assess the reproducibility of the device's output, specifically focusing on predicting the probability of significant curve magnitudes. The study aims to determine if the measurements obtained by different users are congruent, which will support the device's regulatory submission. The NSite device serves as a clinical decision support tool, providing an Asymmetry Index and risk assessment for scoliosis.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10 to 18 years who are being evaluated for or diagnosed with adolescent idiopathic scoliosis.
Not a fit: Patients with scoliosis caused by other conditions or those whose parents cannot provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and reliability of scoliosis monitoring in adolescents, leading to better clinical decision-making.
How similar studies have performed: While the NSite device is investigational, similar approaches using 3D scanning technology have shown promise in other studies for monitoring scoliosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Palo Alto, California
- Lucille Packard Children's Hospital and Clinics — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Kali Tileston, MD — Stanford University
- Study coordinator: Kali R Tileston, MD
- Email: kluker@stanford.edu
- Phone: (650) 497-8891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.