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.
A Retrospective Assessment of OviTex PRS (OviTex)
At a glance
Conditions
Where it's being run
11 sites across 8 statesStudy leadership
- Asaf Yalif, MD · PRINCIPAL_INVESTIGATOR · Y Plastic Surgery
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.24 months
Retrospective - Prospective assessment