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NCT05697939 · ClinicalTrials.gov registry record
3D Body Surface Modeling for Scoliosis Monitoring
A clinical trial of Adolescent Idiopathic Scoliosis, sponsored by Stanford University.
- Recruiting
- Registry status
- 13
- Enrollment target
- 1
- Study location
NCT05697939: Recruiting study of Adolescent Idiopathic Scoliosis, sponsored by Stanford University.
NCT05697939 is a study of Adolescent Idiopathic Scoliosis that is actively recruiting participants, run by Stanford University. The registered enrollment target is 13 participants, below the 276-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05697939, a study of Adolescent Idiopathic Scoliosis, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- 13 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Percentage of scan outputs reproducible. The percentage of scan sets (3 scans for each participant) that have reproducible predicted probabilities for major curve magnitude ≥ 20 degrees. A reproducible output will be defined as a scan set in which all scans have overlapping 95% confidence intervals for the predicted probability of major curve magnitude ≥ 20 degrees.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST NSite 3D Scanning
Study Locations (1)
California
- Lucille Packard Children's Hospital and Clinics - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2030-01-01 |
What NCT05697939 shows while recruiting
NCT05697939 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 276-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Adolescent Idiopathic Scoliosis appearing as the primary indexed condition, and to 1 intervention - of which NSite 3D Scanning is the first listed.
NCT05697939 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05697939 about?
NCT05697939 is a clinical study titled "3D Body Surface Modeling for Scoliosis Monitoring". 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 separa...
What is the current status of trial NCT05697939?
This trial is currently recruiting. The enrollment target is 13 participants. The study started on 2020-08-26. Estimated completion is 2030-01-01.
What conditions does trial NCT05697939 study?
This clinical trial studies the following conditions: Adolescent Idiopathic Scoliosis.
What interventions are being tested in trial NCT05697939?
The interventions under investigation include: NSite 3D Scanning (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05697939?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05697939 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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