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NCT05736848Recruiting

A Retrospective Assessment of OviTex PRS (OviTex)

Tela Bio Inc

Start Date

9/27/2022

Completion Date

12/31/2026

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.

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DEVICE

OviTex® PRS

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Conditions

Reconstructive Surgical Procedures

Locations

Aesthetic Surgery Center

Naples, Florida 34108

United States

Castrellon Aesthetic Surgery

South Miami, Florida 33143

United States

Y Plastic Surgery

Alpharetta, Georgia 30005

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Janineh Plastic Surgery

Rochester Hills, Michigan 48307

United States

David L. Abramson, MD

Englewood, New Jersey 07631

United States

Capital Health

Pennington, New Jersey 08534

United States

Strong Memorial Hospital

Rochester, New York 14642

United States

Plastic Surgery Consultants

Columbia, South Carolina 29201

United States

Dermatology Associates of San Antonio/Baptist Medical Center

San Antonio, Texas 78256

United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas 77385

United States