Trials / Recruiting
RecruitingNCT05736848
A Retrospective Assessment of OviTex PRS (OviTex)
A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Tela Bio Inc · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-09-27
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
- First posted
- 2023-02-21
- Last updated
- 2025-08-15
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05736848. Inclusion in this directory is not an endorsement.