A Retrospective Assessment of OviTex PRS (OviTex)

Description

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

Reconstructive Surgical Procedures

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Study Overview

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Study Details

Study overview

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.

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

A Retrospective Assessment of OviTex PRS (OviTex)

Condition
Reconstructive Surgical Procedures
Intervention / Treatment

-

Contacts and Locations

Alpharetta

Y Plastic Surgery, Alpharetta, Georgia, United States, 30005

Rochester Hills

Janineh Plastic Surgery, Rochester Hills, Michigan, United States, 48307

Englewood

David L. Abramson, MD, Englewood, New Jersey, United States, 07631

Rochester

Strong Memorial Hospital, Rochester, New York, United States, 14642

Columbia

Plastic Surgery Consultants, Columbia, South Carolina, United States, 29201

San Antonio

Dermatology Associates of San Antonio/Baptist Medical Center, San Antonio, Texas, United States, 78256

The Woodlands

Houston Methodist The Woodlands Hospital, The Woodlands, Texas, United States, 77385

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.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tela Bio Inc,

Asaf Yalif, MD, PRINCIPAL_INVESTIGATOR, Y Plastic Surgery

Study Record Dates

2025-12-31