NCT06035952

Study of 3D Scanning for Adolescent Scoliosis

Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: NSite Medical · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an accessible alternative to traditional radiographic workup.

Detailed description

The study design will be prospective observational. Patients 10 to 18 years old being evaluated or followed for scoliosis will be included. Those unable to complete the consent and assent processes will not be enrolled. Members of the research team will review the clinic schedule through EPIC each week to identify eligible patients. Member of the patient's care team, such as the physician, will introduce the study to the patient. If the patient and the patient's caregivers are interested in learning more and/or participating, a member of the research team will provide study-related information and obtain informed consent via written or electronic consent, assent, and, if necessary, short form consent. If a patient consents to participate, members of the research team will conduct the 3D topographical scan in a private room in the clinic. This involves 360 degree scans using a smartphone camera. Participants will also receive any standard of care x-rays during the visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.

Conditions

• Scoliosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	3D topographical scan	Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.

Timeline

• Start date: 2023-08-07
• Primary completion: 2023-10-15
• Completion: 2023-12-15
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study