3D Body Surface Modeling for Scoliosis Monitoring

NCT05697939 | Recruiting FDA Device

• 1 other identifier: 54100
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.

Secondary Outcomes (1)

• User Feedback

  Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.

Study Arms (1)

Adolescent Idiopathic Scoliosis

Reproducibility group

Diagnostic Test: NSite 3D Scanning

Interventions

NSite 3D Scanning DIAGNOSTIC_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.

Adolescent Idiopathic Scoliosis

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adolescent idiopathic scoliosis, ages 10-18

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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital and Clinics

Palo Alto, California, 94304, United States

RECRUITING

Study Officials

• Kali Tileston, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kali R Tileston, MD

CONTACT

(650) 497-8891; kluker@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: January 26, 2023
• Study Start: August 26, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)