3D Body Surface Modeling for Scoliosis Monitoring
Trial ID or NCT#
NCT05697939
Status
RECRUITING
Purpose
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.
Official Title
Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
Eligibility Criteria
Ages Eligible for Study: 10 Years to 18 Years
Sexes Eligible for Study: 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)
Investigator(s)
Kali Tileston
Contact us to find out if this trial is right for you.
Contact
Kali R Tileston, MD
(650) 497-8891
View on ClinicalTrials.gov
