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New device aims to seal aortic aneurysms without open surgery

NCT ID NCT02996396

Disease control Sponsor: Endologix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 48 people who received the Nellix system, a device that seals abdominal aortic aneurysms from the inside using stents and polymer-filled bags. Researchers tracked how well the device worked right after the procedure and for up to 5 years. The goal was to see if the device could prevent rupture and avoid major complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nellix Endovascular Aneurysm Sealing System (a device with stents and polymer-filled bags to seal the aneurysm)
What this could lead to
If successful, this registry could confirm that the Nellix system is a safe and effective way to seal abdominal aortic aneurysms without open surgery.
What could go wrong
This is a small, single-arm observational study with only 48 patients, so results may not apply to everyone. The device may still fail to prevent rupture or require additional procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

48 people

The number who actually took part.

Started

Nov 2016

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female at least 18 years old 2. Subject has signed informed consent for data release 3. Subjects with with AAA and eligible for endovascular repair Exclusion Criteria: 1. Currently participating in another study where primary endpoint has not been reached yet 2. Known allergy to any of the device components 3. Pregnant (females of childbearing potential only)

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal aortic aneurysm

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, New Zealand

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Hospital Universitario y Politécnico de La Fe

    Valencia, 46026, Spain

  • Klinikum Augsburg Klinik für Gefäßchirurgie

    Augsburg, 86156, Germany

  • Rijnstate Hospital

    Arnhem, 90, Netherlands

  • St Elisabeth Ziekenhuis, Dept of Vascular Surgery

    Tilburg, 5022 GC, Netherlands

  • St. Marien Hospital Bonn

    Bonn, 53115, Germany

  • TUM Munich

    Munich, 80333, Germany

  • University Hospital Heidelberg

    Heidelberg, 69120, Germany

  • University Hospital Koeln

    Cologne, 50937, Germany

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