MedTrace Logo

A Retrospective Assessment of OviTex PRS (OviTex)

NCT05736848 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-08-15

No results posted yet for this 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.

Conditions

  • Reconstructive Surgical Procedures

Interventions

DEVICE

OviTex® 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.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Tela Bio Inc

    lead INDUSTRY

Principal Investigators

  • Asaf Yalif, MD · Y Plastic Surgery

Eligibility

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

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05736848 on ClinicalTrials.gov