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Clinical Trials/NCT05697939
NCT05697939Active, not recruitingNot Applicable

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

Stanford University2 sites in 1 country13 target enrollmentStarted: August 26, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
13
Locations
2
Primary Endpoint
Assess the reproducibility of NSite device

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
10 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ages 10 and 18 years old
  • Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis

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)

Outcomes

Primary Outcomes

Assess the reproducibility of NSite device

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

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.

Secondary Outcomes

  • User Feedback(Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Vorhies

Clinical Associate Professor, Orthopaedic Surgery

Stanford University

Study Sites (2)

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