Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:
• Ages 10 and 18 years old
• Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis
Locations
United States
California
Lucille Packard Children's Hospital and Clinics
RECRUITING
Palo Alto
Contact Information
Primary
Kali R Tileston, MD
kluker@stanford.edu
(650) 497-8891
Time Frame
Start Date: 2020-08-26
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 13
Treatments
Adolescent Idiopathic Scoliosis
Reproducibility group
Related Therapeutic Areas
Sponsors
Leads: Stanford University