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Recruiting NCT05697939

NSITE Scoliosis Device Reproducibility Protocol

Conditions: Adolescent Idiopathic Scoliosis

Sex: All

Ages: 10 Years – 18 Years

Enrollment: 13

Sponsor: Stanford University

Location: United States

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 Criteria

Inclusion Criteria:Ages 10 and 18 years oldReferred for evaluation of or diagnosed of adolescent idiopathic scoliosisExclusion Criteria:Scoliosis caused by another condition (e.g., secondary scoliosis)Parents/guardians unable to consentEnglish is not the primary language (to avoid miscommunication)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05697939). StuddyBuddy aggregates publicly available trial information.