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A Retrospective Assessment of OviTex PRS (OviTex)
Sponsor: Tela Bio Inc
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.
Official title: A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2022-09-27
Completion Date
2026-12-31
Last Updated
2025-08-15
Healthy Volunteers
Not specified
Conditions
Interventions
OviTex® PRS
OviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Locations (11)
Aesthetic Surgery Center
Naples, Florida, United States
Castrellon Aesthetic Surgery
South Miami, Florida, United States
Y Plastic Surgery
Alpharetta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Janineh Plastic Surgery
Rochester Hills, Michigan, United States
David L. Abramson, MD
Englewood, New Jersey, United States
Capital Health
Pennington, New Jersey, United States
Strong Memorial Hospital
Rochester, New York, United States
Plastic Surgery Consultants
Columbia, South Carolina, United States
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States