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NCT01419769 · ClinicalTrials.gov registry record · NA
AXIOS Stent & Delivery System Study
A NA study, sponsored by Xlumena.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01419769 is a NA study that has completed, run by Xlumena. The registered enrollment target is 30 participants.
The verdict
NCT01419769, a NA study, has completed, sponsored by Xlumena.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA). The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.
Interventions
- DEVICE AXIOS Stent & Delivery System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01419769
The ClinicalTrials.gov registry entry for NCT01419769 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xlumena, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AXIOS Stent & Delivery System is the first listed.
NCT01419769 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01419769 about?
NCT01419769 is a clinical study titled "AXIOS Stent & Delivery System Study". The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA). The study design is prospective, multi-center, non-blinded, single-arm (nonran...
What is the current status of trial NCT01419769?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-08. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01419769?
The interventions under investigation include: AXIOS Stent & Delivery System (DEVICE).
Who is sponsoring clinical trial NCT01419769?
This trial is sponsored by Xlumena, which has 2 total clinical trials registered on ClinicalTrials.gov.
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