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NCT04106583 · ClinicalTrials.gov registry record

Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

A clinical trial, sponsored by Penumbra.

Completed
Registry status
572
Enrollment target

NCT04106583 is a clinical trial that has completed, run by Penumbra. The registered enrollment target is 572 participants.

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The verdict

NCT04106583 has completed, sponsored by Penumbra.

COMPLETED
Registry status
572 participants
Enrollment target

Study Summary

The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.

Interventions

  • DEVICE WAVE, as part of the SMART COIL System

Trial Details

FieldValue
Enrollment Target 572 participants
Start Date 2019-11-05
Est. Completion 2023-08-02

Sponsor

Penumbra

25 total trials

What the Registry Record Tells You About NCT04106583

The ClinicalTrials.gov registry entry for NCT04106583 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 572 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which WAVE, as part of the SMART COIL System is the first listed.

NCT04106583 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04106583 about?

NCT04106583 is a clinical study titled "Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities". The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusio...

What is the current status of trial NCT04106583?

This trial is currently completed. The enrollment target is 572 participants. The study started on 2019-11-05. Estimated completion is 2023-08-02.

What interventions are being tested in trial NCT04106583?

The interventions under investigation include: WAVE, as part of the SMART COIL System (DEVICE).

Who is sponsoring clinical trial NCT04106583?

This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.