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Recruiting NCT05736848

A Retrospective Assessment of OviTex PRS (OviTex)

— Observational Reconstructive Surgical Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OviTex® PRS.
Who it may be relevant to
Registry conditions: Reconstructive Surgical Procedures. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation. [Time frame: 24 months]
Secondary outcome measures (5)
  • Time to Expander/Implant Exchange [Time frame: 24-months]
  • Intraoperative Fill Volume / Number and Volume of Fill Visits [Time frame: 24 months]
  • Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score [Time frame: 24 months]
  • Independent assessment of breast ptosis as measured by the Rainbow Scale [Time frame: 24-months]
  • Hospitalization length of stay [Time frame: At procedure]

Eligibility criteria

Inclusion criteria

  • Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
  • At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.
  • Patient has undergone their initial surgical procedure and exchange surgery (if applicable).

Exclusion criteria

  • Patient received a textured permanent breast implant.
  • Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
  • Patient had previously undergone radiation therapy to the chest wall prior to index surgery.

Additional prospective inclusion criteria (if applicable):

1\. Patient agrees to return in-person for prospective portion including the completion of photographs.

Additional prospective exclusion criteria (if applicable):

1\. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

United States · 11 centers
  • Aesthetic Surgery Center — Naples
  • Castrellon Aesthetic Surgery — South Miami
  • Y Plastic Surgery — Alpharetta
  • Massachusetts General Hospital — Boston
  • Janineh Plastic Surgery — Rochester Hills
  • David L. Abramson, MD — Englewood
  • Capital Health — Pennington
  • Strong Memorial Hospital — Rochester
  • … and 3 more centers

Identifiers

NCT: NCT05736848 · TB2022.01.02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗