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NCT03333941 · ClinicalTrials.gov registry record
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
A clinical trial, sponsored by Avita Medical.
- Completed
- Registry status
- 76
- Enrollment target
NCT03333941: Completed study, sponsored by Avita Medical.
NCT03333941 is a clinical trial that has completed, run by Avita Medical. The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03333941 has completed, sponsored by Avita Medical.
- COMPLETED
- Registry status
- 76 participants
- Enrollment target
Study Summary
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.
Primary Outcome
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
Interventions
- DEVICE ReCell® Autologous Cell Harvesting Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-10-26 |
| Est. Completion | 2019-05-08 |
What the finished NCT03333941 record still lists
NCT03333941 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ReCell® Autologous Cell Harvesting Device is the first listed.
NCT03333941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03333941 about?
NCT03333941 is a clinical study titled "Continued Access to the Recell® Device for Treatment of Acute Burn Injuries". The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to ...
What is the current status of trial NCT03333941?
This trial is currently completed. The enrollment target is 76 participants. The study started on 2017-10-26. Estimated completion is 2019-05-08.
What interventions are being tested in trial NCT03333941?
The interventions under investigation include: ReCell® Autologous Cell Harvesting Device (DEVICE).
Who is sponsoring clinical trial NCT03333941?
This trial is sponsored by Avita Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
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