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Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

NCT07135596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2026-05-06

No results posted yet for this study

Summary

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

Conditions

  • Breast Reconstruction

Interventions

DEVICE

OviTex PRS

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

Sponsors & Collaborators

  • Tela Bio Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2030-06-30
Completion
2034-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135596 on ClinicalTrials.gov