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NCT05163548 · ClinicalTrials.gov registry record · NA
PerQseal®+ Early Feasibility Study
A NA study, sponsored by Vivasure Medical Limited.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT05163548: Completed NA study, sponsored by Vivasure Medical Limited.
NCT05163548 is a NA study that has completed, run by Vivasure Medical Limited. The registered enrollment target is 15 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
NCT05163548, a NA study, has completed, sponsored by Vivasure Medical Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.
Primary Outcome
The primary safety endpoint is the rate of major access site complications attributable to the PerQseal® device. As per FDA definitions for Major access site complications.
Interventions
- DEVICE PerQseal Plus Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2022-07-07 |
| Phase | NA |
What the finished NCT05163548 record still lists
NCT05163548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 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 PerQseal Plus Device is the first listed.
NCT05163548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05163548 about?
NCT05163548 is a clinical study titled "PerQseal®+ Early Feasibility Study". The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects u...
What is the current status of trial NCT05163548?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2022-03-08. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT05163548?
The interventions under investigation include: PerQseal Plus Device (DEVICE).
Who is sponsoring clinical trial NCT05163548?
This trial is sponsored by Vivasure Medical Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05163548's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 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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