Actively Recruiting
A Retrospective Assessment of OviTex PRS (OviTex)
Led by Tela Bio Inc · Updated on 2025-08-15
200
Participants Needed
11
Research Sites
222 weeks
Total Duration
On this page
Sponsors
T
Tela Bio Inc
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Retrospective Assessment of OviTex PRS (OviTex)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
- Patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant during implant-based breast reconstruction.
- Patient underwent initial surgical procedure and exchange surgery if applicable.
- Patient agrees to return in-person for prospective portion including photographs (if applicable).
You will not qualify if you...
- Patient received a textured permanent breast implant.
- Patient used nicotine products (including smokeless, vaporized, etc.) within 4 weeks before their surgery.
- Patient had radiation therapy to the chest wall before surgery.
- Patient has a history of psychological conditions, drug, or alcohol abuse that may affect follow-up adherence (for prospective portion).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Aesthetic Surgery Center
Naples, Florida, United States, 34108
Actively Recruiting
2
Castrellon Aesthetic Surgery
South Miami, Florida, United States, 33143
Actively Recruiting
3
Y Plastic Surgery
Alpharetta, Georgia, United States, 30005
Active, Not Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Janineh Plastic Surgery
Rochester Hills, Michigan, United States, 48307
Completed
6
David L. Abramson, MD
Englewood, New Jersey, United States, 07631
Actively Recruiting
7
Capital Health
Pennington, New Jersey, United States, 08534
Actively Recruiting
8
Strong Memorial Hospital
Rochester, New York, United States, 14642
Completed
9
Plastic Surgery Consultants
Columbia, South Carolina, United States, 29201
Actively Recruiting
10
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas, United States, 78256
Completed
11
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States, 77385
Actively Recruiting
Research Team
Z
Zachary Sterner
CONTACT
D
Danielle Campbell
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here