A Retrospective Assessment of OviTex PRS (OviTex)

Last updated: March 26, 2025
Sponsor: Tela Bio Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

OviTex® PRS

Clinical Study ID

NCT05736848
TB2022.01.02
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 orR20243) or Resorbable (R20152 or R20252) implant in conjunction with animplant-based breast reconstruction.

  3. Patient has undergone their initial surgical procedure and exchange surgery (ifapplicable).

Exclusion

Exclusion Criteria:

  1. Patient received a textured permanent breast implant.

  2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weekspreceeding their index procedure.

  3. Patient had previously undergone radiation therapy to the chest wall prior to indexsurgery.

Additional prospective inclusion criteria (if applicable):

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

Additional prospective exclusion criteria (if applicable):

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: OviTex® PRS
Phase:
Study Start date:
September 27, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Aesthetic Surgery Center

    Naples, Florida 34108
    United States

    Active - Recruiting

  • Castrellon Aesthetic Surgery

    South Miami, Florida 33143
    United States

    Active - Recruiting

  • Y Plastic Surgery

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Y Plastic Surgery

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Janineh Plastic Surgery

    Rochester Hills, Michigan 48307
    United States

    Completed

  • David L. Abramson, MD

    Englewood, New Jersey 07631
    United States

    Active - Recruiting

  • Capital Health

    Pennington, New Jersey 08534
    United States

    Active - Recruiting

  • Stong Memorial Hospital

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Strong Memorial Hospital

    Rochester, New York 14642
    United States

    Completed

  • Plastic Surgery Consultants

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Dermatology Associates of San Antonio/Baptist Medical Center

    San Antonio, Texas 78256
    United States

    Completed

  • Houston Methodist The Woodlands Hospita

    The Woodlands, Texas 77385
    United States

    Active - Recruiting

  • Houston Methodist The Woodlands Hospital

    The Woodlands, Texas 77385
    United States

    Active - Recruiting

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