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3D Body Surface Modeling for Scoliosis Monitoring

NCT05697939 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2025-04-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

NSite 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.

Sponsors & Collaborators

Principal Investigators

  • Kali Tileston, MD · Stanford University

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2030-01-01
Completion
2030-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697939 on ClinicalTrials.gov