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NCT04119284 · ClinicalTrials.gov registry record · NA
Safety Outcomes of Vertebral Body Tethering Technique
A NA study, sponsored by Nemours Children's Clinic.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT04119284: Clinical Trial NA study, sponsored by Nemours Children's Clinic.
NCT04119284 is a NA study that was terminated before completion, run by Nemours Children's Clinic. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04119284, a NA study, was terminated before completion, sponsored by Nemours Children's Clinic.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
The objectives of this study is to assess whether the intervention (Anterior Vertebral Tethering) is a safe and efficacious method of anterior approach surgery for spinal deformity in pediatric scoliosis.
Primary Outcome
We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections. Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases. The PI will determine if these events are related to the device.
Interventions
- DEVICE Anterior body tether (ABT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2023-12-15 |
| Phase | NA |
Why NCT04119284 stopped before completion
NCT04119284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Anterior body tether (ABT) is the first listed.
NCT04119284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04119284 about?
NCT04119284 is a clinical study titled "Safety Outcomes of Vertebral Body Tethering Technique". The objectives of this study is to assess whether the intervention (Anterior Vertebral Tethering) is a safe and efficacious method of anterior approach surgery for spinal deformity in pediatric scoliosis.
What is the current status of trial NCT04119284?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2019-09-01. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT04119284?
The interventions under investigation include: Anterior body tether (ABT) (DEVICE).
Who is sponsoring clinical trial NCT04119284?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04119284's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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