RecruitingNot ApplicableNCT07135596

Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation


Sponsor

Tela Bio Inc

Enrollment

235 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.


Eligibility

Sex: FEMALEMin Age: 22 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 breast reconstruction. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 22 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

A multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament.


Locations(2)

Qualmedica Research

Bowling Green, Kentucky, United States

WakeMed

Raleigh, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT07135596


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