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NCT02122133 · ClinicalTrials.gov registry record
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
A clinical trial, sponsored by Penumbra.
- Terminated
- Registry status
- 67
- Enrollment target
NCT02122133: Clinical Trial study, sponsored by Penumbra.
NCT02122133 is a clinical trial that was terminated before completion, run by Penumbra. The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02122133 was terminated before completion, sponsored by Penumbra.
- TERMINATED
- Registry status
- 67 participants
- Enrollment target
Study Summary
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
Primary Outcome
Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.
Interventions
- DEVICE PC 400
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-10-19 |
Why NCT02122133 stopped before completion
NCT02122133 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 67 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which PC 400 is the first listed.
NCT02122133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02122133 about?
NCT02122133 is a clinical study titled "CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400". The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms wh...
What is the current status of trial NCT02122133?
This trial is currently terminated. The enrollment target is 67 participants. The study started on 2015-05. Estimated completion is 2016-10-19.
What interventions are being tested in trial NCT02122133?
The interventions under investigation include: PC 400 (DEVICE).
Who is sponsoring clinical trial NCT02122133?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
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