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New carbon fiber plates could make heart surgery recovery safer

NCT ID NCT07366203

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new device—adjustable carbon fiber plates—to close the breastbone after open-heart surgery, compared to standard stainless steel wires. About 190 adults having heart surgery will be randomly assigned to one method. The main goal is to see if the plates keep the breastbone stable one month after surgery, with follow-up at six months to check for safety issues like infections or the need for another operation.

What this could mean

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

Active substance
adjustable carbon fiber sternal plates
What this could lead to
If successful, this device could offer a more stable and safer way to close the breastbone after heart surgery, reducing complications like infection or reoperation.
What could go wrong
This is an early-stage device trial with no phase designation, so results may not confirm superiority over standard wires. Risks include device deficiencies, infections, or need for reintervention.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

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: * Patient ≥ 18 years old. * Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated. * Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained. * Patient able and willing to meet the protocol requirements and to follow postoperative care instructions Exclusion Criteria: * Patient with sternal anomalies, such as bone tumours located in the sternum. * Patient with limited sternum bone blood supply. * Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel. * Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum. * Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery. * Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain. * Patient with diagnosis of dementia with a mental status score (MMSE) \< 20. * Patient with life expectancy lower than 6 months. * Patient with any other medical process that may compromise or limit the adequate functionality of the implants. * Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks. * Patient with signs of latent or active infection or inflammation on the surgical site. * Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage. * Patient for whom the closure technique cannot ensure sufficient sternal fixation. * Parasternal sternotomy. * Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use

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As listed by the trial registrant

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How to take part

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