RECRUITING

3D Body Surface Modeling for Scoliosis Monitoring

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-08-26
Study Completion:2030-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05697939

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 10 and 18 years old
  2. * Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis
  1. * Scoliosis caused by another condition (e.g., secondary scoliosis)
  2. * Parents/guardians unable to consent
  3. * English is not the primary language (to avoid miscommunication)

Contacts and Locations

Study Contact

Kali R Tileston, MD
CONTACT
(650) 497-8891
kluker@stanford.edu

Principal Investigator

Kali Tileston, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Lucille Packard Children's Hospital and Clinics
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Kali Tileston, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-26
Study Completion Date2030-01-01

Study Record Updates

Study Start Date2020-08-26
Study Completion Date2030-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Adolescent Idiopathic Scoliosis