Adolescent Idiopathic ScoliosisNCT05697939
3D Body Surface Modeling for Scoliosis Monitoring
An observational study of Adolescent Idiopathic Scoliosis, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- NSite 3D Scanning
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 1 Jan 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with adolescent idiopathic scoliosis, ages 10-18
Who may be able to join
- Ages 10 and 18 years old
- Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis
Who cannot join
- Scoliosis caused by another condition (e.g., secondary scoliosis)
- Parents/guardians unable to consent
- English is not the primary language (to avoid miscommunication)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital and Clinics
Palo Alto, California, 94304
About this study
Official title: Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
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.
Read the detailed 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 determine if they are congruent (having overlapping confidence intervals) or different. The percentage of participants for which users generated congruent predicted probabilities will be reported.
The NSite Scoliosis Assessment App is intended as a clinical decision support tool and requires interpretation by the healthcare professional. It is intended for use for children and adolescent patients 10 to 18 years old. It is for use by prescription only. The NSite Scoliosis Assessment App provides a calculated Asymmetry Index for patients with or at risk for scoliosis, which will yield an output of percentage risk of major curve magnitude (i.e., Cobb angle) greater than 20 degrees, with 95% confidence intervals.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- NSite 3D Scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSite 3D ScanningDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Idiopathic Scoliosis | Reproducibility group Receives: Diagnostic Test: NSite 3D Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the reproducibility of NSite device
Percentage of scan outputs reproducible. The percentage of scan sets (3 scans for each participant) that have reproducible predicted probabilities for major curve magnitude ≥ 20 degrees. A reproducible output will be defined as a scan set in which all scans have overlapping 95% confidence intervals for the predicted probability of major curve magnitude ≥ 20 degrees.
Measured: Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.
Secondary outcomes (1)
User Feedback
User feedback will be collected throughout testing in the form of open-ended comments. These will be collated and reported.
Measured: Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start26 Aug 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Vorhies, Stanford University
- Investigators
- John S Vorhies, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697939
- Sponsor's protocol ID
- 54100
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No