Observational Study of OviTex PRS in Breast Reconstruction

This study is looking back at how safe OviTex® PRS (a reinforced tissue matrix used to support soft tissue) has been for patients who had it placed during breast reconstruction surgery. Researchers are specifically interested in patients who received an OviTex PRS Permanent or Resorbable implant as part of their implant-based breast reconstruction. The study will look at any relevant side effects (SAEs) that occurred within 24 months after the OviTex® PRS was implanted. You might be eligible if you are a woman between 18 and 75 years old who has already had this type of breast reconstruction. The study aims to enroll 200 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers are looking at existing patient data rather than assigning treatments. It is a multi-center study, aiming to include 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will look at side effects for up to 24 months after the OviTex® PRS was implanted.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05736848

A Retrospective Assessment of OviTex PRS (OviTex)

Active, Not Recruiting
Not specifiedAges 18–75Observational
Tela Bio Inc
~200 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:OviTex® PRS

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
Measured over 24 months
Reconstructive Surgical Procedures
11 sites across 8 states
Florida2
New Jersey2
Texas2
Georgia1
Massachusetts1
Michigan1
New York1
South Carolina1
  • Asaf Yalif, MD · PRINCIPAL_INVESTIGATOR · Y Plastic Surgery

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.24 months

    Retrospective - Prospective assessment