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NCT04645173 · ClinicalTrials.gov registry record
Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation
A clinical trial, sponsored by Elutia.
- Completed
- Registry status
- 46
- Enrollment target
NCT04645173: Completed study, sponsored by Elutia.
NCT04645173 is a clinical trial that has completed, run by Elutia. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04645173 has completed, sponsored by Elutia.
- COMPLETED
- Registry status
- 46 participants
- Enrollment target
Study Summary
The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.
Primary Outcome
Microscopic analysis of cellularity, vascularity, collagen density, necrosis, infectious agents, remnant device material, giant cells, and fibrotic capsule thickness will be evaluated for each biopsy site using a quantitative scoring system with an attempt to distinguish between remnant envelope collagen (if ECM envelope was used) and neocollagen from the participant. Composite (total) and average scores will be determined based on the individual scores from each biopsy site. The quantitative th
Interventions
- DEVICE CIED envelope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-02-02 |
| Est. Completion | 2023-12-31 |
What the finished NCT04645173 record still lists
NCT04645173 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 46 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CIED envelope is the first listed.
NCT04645173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04645173 about?
NCT04645173 is a clinical study titled "Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation". The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.
What is the current status of trial NCT04645173?
This trial is currently completed. The enrollment target is 46 participants. The study started on 2021-02-02. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04645173?
The interventions under investigation include: CIED envelope (DEVICE).
Who is sponsoring clinical trial NCT04645173?
This trial is sponsored by Elutia, which has 10 total clinical trials registered on ClinicalTrials.gov.
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