A Retrospective Assessment of OviTex PRS (OviTex)

Launched by TELA BIO INC · Feb 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of a medical device called OviTex PRS, which is used in breast reconstruction surgery. The study will review past surgeries where patients received either a permanent or a resorbable OviTex implant to see how well they worked and if there were any complications. The trial aims to gather information about the experiences of women who have had this type of surgery, focusing on those who are between 18 and 75 years old and have received the OviTex implants during their breast reconstruction.

To participate in this trial, women must be within the specified age range and have had surgery where they received an OviTex implant. They cannot have had certain types of breast implants or used nicotine products recently. Participants can expect to provide information about their surgery experiences and may need to return for follow-up visits, which could include taking photographs. Overall, this study aims to better understand how safe and effective OviTex PRS implants are for women undergoing breast reconstruction.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
• • 2. 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.
• • 3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).
• Exclusion Criteria:
• • 1. Patient received a textured permanent breast implant.
• • 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
• • 3. 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.