RecruitingNCT05736848

A Retrospective Assessment of OviTex PRS (OviTex)

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

Sponsor

Tela Bio Inc

Enrollment

200 participants

Start Date

Sep 27, 2022

Study Type

OBSERVATIONAL

Conditions

Reconstructive Surgical Procedures

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called OviTex® PRS for people with reconstructive surgical procedures. The study is currently recruiting participants at 11 locations. People eligible for this study include women aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOviTex® PRS

OviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Locations(11)

Aesthetic Surgery Center

Naples, Florida, United States

Castrellon Aesthetic Surgery

South Miami, Florida, United States

Y Plastic Surgery

Alpharetta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Janineh Plastic Surgery

Rochester Hills, Michigan, United States

David L. Abramson, MD

Englewood, New Jersey, United States

Capital Health

Pennington, New Jersey, United States

Strong Memorial Hospital

Rochester, New York, United States

Plastic Surgery Consultants

Columbia, South Carolina, United States

Dermatology Associates of San Antonio/Baptist Medical Center

San Antonio, Texas, United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05736848

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