A Retrospective Assessment of OviTex PRS (OviTex) (PRS)

August 14, 2025 updated by: Tela Bio Inc

A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Naples, Florida, United States, 34108
        • Recruiting
        • Aesthetic Surgery Center
        • Contact:
        • Principal Investigator:
          • Casey Holmes, MD
      • South Miami, Florida, United States, 33143
        • Recruiting
        • Castrellon Aesthetic Surgery
        • Contact:
        • Principal Investigator:
          • Ricardo Castrellon, MD, P.A.
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Active, not recruiting
        • Y Plastic Surgery
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Katherine Carruthers, MD
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Completed
        • Janineh Plastic Surgery
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • David L. Abramson, MD
        • Contact:
        • Principal Investigator:
          • David Abramson, MD
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Capital Health
        • Contact:
        • Principal Investigator:
          • Gary Tuma, MD, FACS
    • New York
      • Rochester, New York, United States, 14642
        • Completed
        • Strong Memorial Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • Texas
      • San Antonio, Texas, United States, 78256
        • Completed
        • Dermatology Associates of San Antonio/Baptist Medical Center
      • The Woodlands, Texas, United States, 77385
        • Recruiting
        • Houston Methodist The Woodlands Hospital
        • Contact:
        • Principal Investigator:
          • Steven Albright, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Data will be collected for 200 subjects that have been implanted with OviTex® PRS

Description

Inclusion Criteria:

  1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
  2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.
  3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).

Exclusion Criteria:

  1. Patient received a textured permanent breast implant.
  2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
  3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery.

Additional prospective inclusion criteria (if applicable):

1. Patient agrees to return in-person for prospective portion including the completion of photographs.

Additional prospective exclusion criteria (if applicable):

1. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
Time Frame: 24 months
Retrospective - Prospective assessment
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization length of stay
Time Frame: At procedure
Retrospective - Prospective assessment
At procedure
Time to Expander/Implant Exchange
Time Frame: 24-months
Retrospective - Prospective assessment
24-months
Intraoperative Fill Volume / Number and Volume of Fill Visits
Time Frame: 24 months
Retrospective - Prospective assessment
24 months
Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score
Time Frame: 24 months
Image aesthetic assessment
24 months
Independent assessment of breast ptosis as measured by the Rainbow Scale
Time Frame: 24-months
Retrospective - Prospective assessment
24-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tela Bio Inc

Collaborators

MCRA

Investigators

  • Principal Investigator: Asaf Yalif, MD, Y Plastic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TB2022.01.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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