New carbon fiber plates could make heart surgery recovery safer
NCT ID NCT07366203
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
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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
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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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