Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
Stanford University
Summary
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.
Description
The primary objective of this study is to validate the reproducibility of device output in multiple users in a clinical setting. Device output will be predicted probability of major curve magnitude (i.e., Cobb angle) greater than or equal to 20 degrees with 95% confidence interval. We will test whether users obtain similar device output when measuring the same participant (at least 2 scans required for analysis). After excluding bad quality scans, the measurements obtained by these different users (at least 2 users after excluding bad scans) on each study participant will then be compared to d…
Eligibility
- Age range
- 10–18 years
- Sex
- All
- Healthy volunteers
- No
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)
Interventions
- Diagnostic TestNSite 3D Scanning
Three separate users will enter the exam room and use the NSite application to scan the patient in the bending position. These users may include research coordinators, physicians, or other authorized staff. The NSite application will have a user tutorial on how to scan patients that users are instructed to watch prior to conducting a scan. All participants are asked to remove clothing above the waist but may keep a bra or tight-fitting shirt on during the scanning procedures. The patient will be asked to assume a forward bending position. One user will capture a scan of the patient's back in this position. The user will calibrate the device and then walk around the patient while scanning per app directions. Once this user captures the scan, it will be processed by the application. New scans will then be obtained by the two other users. Once all users have captured a scan, the scanning process and patient participation will be completed.
Location
- Lucille Packard Children's Hospital and ClinicsPalo Alto, California