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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Reconstructive Surgical Procedures

NCT number NCT05736848
Study type Observational
Source Tela Bio Inc
Contact Zachary Sterner
Phone 937-514-2262
Email zsterner@telabio.com
Status Recruiting
Phase
Start date September 27, 2022
Completion date March 31, 2025

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