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New device may cut opioid use after Open-Heart surgery

NCT ID NCT07215546

Symptom relief Sponsor: Abyrx, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using Montage or Montage-CT devices to close the breastbone after heart surgery can lower the need for strong painkillers like opioids. Researchers will review records from 150 adults who had planned heart surgery. They will compare opioid use and recovery time between patients who got the device and those who had standard closure.

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

About 150 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Apr 2026

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.

Who is studied

Males and females age \> 19 years of age who have undergone non-emergent cardiac surgery (coronary artery by-pass grafting \[CABG\] and/or single valve replacement procedure).

Ages

19 to 80 years

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 \> 19 years of age. 2. Underwent non-emergent cardiac surgery (isolated coronary artery by-pass grafting and/or isolated valve surgery). 3. Full median sternotomy approach - with/without cardiopulmonary bypass. Exclusion Criteria: 1. Recent CPR. 2. Previous cardiac surgery (redo sternotomy). 3. Emergency surgery (operative intervention within 24 hrs of assessment). 4. Chronic lung disease. 5. BMI \> 40. 6. Use of sternal plate systems for closure. 7. Recent antiplatelet therapy. 8. Previous radiotherapy to the chest; receiving immunosuppressive therapy or have a current immunosuppressive condition. 9. Active systemic infection (.i.e: endocarditis). 10. Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse). 11. History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence) 12. Recent history of drug or alcohol abuse. 13. Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability. 14. Postsurgical life expectancy \< 90 days in the opinion of the investigator. 14\. Moderate or severe pectus deformity. 16. Participation in another clinical trial. 17. Patients who had Patient-Controlled Analgesia (PCA) devices after surgery. 18. Patients who received a local anesthetic treatment and/or device on the sternum intraoperatively during surgery (e.g. On-Q Pain Relief System, Exparel etc)

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Conditions

The condition(s) this trial relates to.

agnosia

As listed by the trial registrant

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

Cerclage Pain management Retrospective review

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • NCH Rooney Heart Institute

    Naples, Florida, 34102, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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