Clinical Trial

A Retrospective Assessment of OviTex PRS (OviTex)

Study acronym: PRS
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 15, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-02-20; most recent amendment 2025-08-14.
Trial Details
NCT Number NCT05736848
Lead Sponsor Tela Bio Inc
Collaborators: MCRA
Conditions Reconstructive Surgical Procedures
Enrollment 200 participants
Start Date 2022-09-27
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-15