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Can a reinforced tissue matrix improve breast reconstruction safety?

NCT ID NCT05736848

Knowledge-focused Sponsor: Tela Bio 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This observational study looks back at the experiences of 200 people who had breast reconstruction surgery using a device called OviTex PRS. The goal is to understand how safe this device is by tracking any complications that occurred within two years of the surgery. The study also examines how well the reconstruction looked and how the surgical process went. By reviewing past cases, researchers hope to gather useful information about the device's performance in real-world settings.

What this could mean

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

Active substance
OviTex PRS, a reinforced tissue matrix used to support soft tissue during implant-based breast reconstruction
What this could lead to
If successful, this study could provide valuable safety data on OviTex PRS, helping surgeons make informed decisions about its use in breast reconstruction.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be limited by the retrospective design and potential biases.

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 200 people

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

Started

Sep 2022

Expected to finish

Dec 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

Data will be collected for 200 subjects that have been implanted with OviTex® PRS

Ages

18 to 75 years

Sex

Female participants only

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. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery. 2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction. 3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable). Exclusion Criteria: 1. Patient received a textured permanent breast implant. 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure. 3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery. Additional prospective inclusion criteria (if applicable): 1\. Patient agrees to return in-person for prospective portion including the completion of photographs. Additional prospective exclusion criteria (if applicable): 1\. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.

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As listed by the trial registrant

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

Reconstructive surgical procedures

Contacts and locations

Locations

  • Aesthetic Surgery Center

    Naples, Florida, 34108, United States

  • Capital Health

    Pennington, New Jersey, 08534, United States

  • Castrellon Aesthetic Surgery

    South Miami, Florida, 33143, United States

  • David L. Abramson, MD

    Englewood, New Jersey, 07631, United States

  • Dermatology Associates of San Antonio/Baptist Medical Center

    San Antonio, Texas, 78256, United States

  • Houston Methodist The Woodlands Hospital

    The Woodlands, Texas, 77385, United States

  • Janineh Plastic Surgery

    Rochester Hills, Michigan, 48307, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Plastic Surgery Consultants

    Columbia, South Carolina, 29201, United States

  • Strong Memorial Hospital

    Rochester, New York, 14642, United States

  • Y Plastic Surgery

    Alpharetta, Georgia, 30005, United States

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