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Heart surgery device study pulled before it began

NCT ID NCT05784532

Knowledge-focused Sponsor: NEOS Surgery 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 was designed to observe how well a device called STERN FIX works to close the breastbone after heart surgery. It planned to enroll adults having heart surgery that requires opening the breastbone. The study was withdrawn before any participants were enrolled, so no results are available.

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.

Started

Apr 2023

Finished

Jan 2025

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

All those patients that have or will undergo medial sternotomy during the registry period will be considered for inclusion. They will be informed about it, and if they consent for their data to be used in the registry, their eligibility will be assessed. If a patient does not comply with all IFUs indications, they will not be included in the registry

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: * Older than 18 years old patient * Patient undergoing surgery requiring medial sternotomy * Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry Exclusion Criteria: * Patients that are still growing. * Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region. * Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage. * Patients with suspected or known allergies or intolerances to the implant material. * Patients with severe osteoporosis or other degenerative bone diseases. * Any patient unwilling to, or incapable of, following postoperative care instructions. * Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant. * Pregnant patients or planning to become pregnant during the 2 months following surgery. * Patients with life expectancy lower than 2 months. * Patients who are or have been participating in an interventionist trial during the last 4 weeks Intraoperative exclusion criteria * Latent or active infection, or inflammation in the operating area. * Signs of infection on the surgical site. * Parasternal sternotomy. * When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation. * When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.

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As listed by the trial registrant

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

Sternotomy

Contacts and locations

Locations

  • New York-Presbyterian Hospital

    Ney York, New York, 10032, United States

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