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

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: Active, not recruiting
• Conditions: Reconstructive Surgical Procedures
• Intervention / Treatment: Device: OviTex® PRS

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

Study Locations

• United States
  • Florida
    • Naples, Florida, United States, 34108
      • Aesthetic Surgery Center
    • South Miami, Florida, United States, 33143
      • Castrellon Aesthetic Surgery
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Y Plastic Surgery
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Janineh Plastic Surgery
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • David L. Abramson, MD
    • Pennington, New Jersey, United States, 08534
      • Capital Health
  • New York
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Plastic Surgery Consultants
  • Texas
    • San Antonio, Texas, United States, 78256
      • Dermatology Associates of San Antonio/Baptist Medical Center
    • The Woodlands, Texas, United States, 77385
      • Houston Methodist The Woodlands Hospital

Participation Criteria

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

How is the study designed?

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.	Retrospective - Prospective assessment	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tela Bio Inc
• Collaborators: MCRA
• Investigators: Principal Investigator: Asaf Yalif, MD, Y Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Estimated): August 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 (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

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