3D Body Surface Modeling for Scoliosis Monitoring

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05697939
Study type	Observational
Source	Stanford University
Contact	Kali R Tileston, MD
Phone	(650) 497-8891
Email	kluker@stanford.edu
Status	Recruiting
Phase
Start date	August 26, 2020
Completion date	January 1, 2030

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03935295` - Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis	Phase 4
Recruiting	`NCT06262269` - Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents	N/A
Not yet recruiting	`NCT06003010` - Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients	N/A
Withdrawn	`NCT02590380` - Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity	N/A
Completed	`NCT02302534` - Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)	N/A
Completed	`NCT05669859` - Efficacy of Postoperative Telerehabilitation in Adolescent Idiopathic Scoliosis	N/A
Completed	`NCT05242601` - Investigation of Quality of Life in Adolescent Idiopathic Scoliosis
Recruiting	`NCT05969301` - Memory and Scoliosis Spinal Exercises
Recruiting	`NCT05919459` - Effectiveness of Acceptance and Commitment Therapy Versus Active Controls in Improving Psychological Functions of Parents and Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial	N/A
Enrolling by invitation	`NCT05790031` - Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis	N/A
Active, not recruiting	`NCT04867148` - The Prediction and Prevention of Disease by Using Big Data in Motion Analysis	N/A
Completed	`NCT05056363` - The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis	N/A
Completed	`NCT00989495` - Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study	N/A
Withdrawn	`NCT00958373` - Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis	N/A
Recruiting	`NCT05730920` - IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction	Phase 4
Recruiting	`NCT03292601` - Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)	N/A
Completed	`NCT04421157` - Exercises in Adolescent Idiopathic Scoliosis	N/A
Completed	`NCT05127902` - Association Between Postural Balance and Muscle Activity of the Lumbar and Lower Limb Muscles in Female With or Without Adolescent Idiopathic Scoliosis (AIS) During Standing Balance Tasks With Upper Limb Movement
Completed	`NCT05703737` - Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis
Completed	`NCT04092335` - Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis