A Retrospective Assessment of OviTex PRS (OviTex)
Start Date
9/27/2022
Completion Date
12/31/2026
Summary
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
Detailed Description
This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
OviTex® PRS
Conditions
Locations
Aesthetic Surgery Center
Naples, Florida 34108
United States
Castrellon Aesthetic Surgery
South Miami, Florida 33143
United States
Y Plastic Surgery
Alpharetta, Georgia 30005
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Janineh Plastic Surgery
Rochester Hills, Michigan 48307
United States
David L. Abramson, MD
Englewood, New Jersey 07631
United States
Capital Health
Pennington, New Jersey 08534
United States
Strong Memorial Hospital
Rochester, New York 14642
United States
Plastic Surgery Consultants
Columbia, South Carolina 29201
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