Study of 3D Scanning for Adolescent Scoliosis

NCT ID: NCT06035952

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2023-12-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

This study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray.

3D topographical scan

Intervention Type: DIAGNOSTIC_TEST

Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.

Interventions

3D topographical scan

Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Ages 10 and 18 years old

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NSite Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kali Tileston, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Palo Alto, California, United States

Site Status: RECRUITING

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael J. Gardner, MD

Role: CONTACT

mike@nsitemedical.com

9175846909

Facility Contacts

Kali Tileston

Role: primary

kluker@stanford.edu

650-723-5243

Anthony Catanzano, MD

Role: primary

anthony.catanzano@duke.edu

919-613-7797

Other Identifiers

54101

Identifier Type: -

Identifier Source: org_study_id