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RECRUITING
NCT05736848

A Retrospective Assessment of OviTex PRS (OviTex)

Sponsor: Tela Bio Inc

View on ClinicalTrials.gov

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.

Official title: A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2022-09-27

Completion Date

2026-12-31

Last Updated

2025-08-15

Healthy Volunteers

Not specified

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.

Locations (11)

Aesthetic Surgery Center

Naples, Florida, United States

Castrellon Aesthetic Surgery

South Miami, Florida, United States

Y Plastic Surgery

Alpharetta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Janineh Plastic Surgery

Rochester Hills, Michigan, United States

David L. Abramson, MD

Englewood, New Jersey, United States

Capital Health

Pennington, New Jersey, United States

Strong Memorial Hospital

Rochester, New York, United States

Plastic Surgery Consultants

Columbia, South Carolina, United States

Dermatology Associates of San Antonio/Baptist Medical Center

San Antonio, Texas, United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States