A Retrospective Assessment of OviTex PRS (OviTex)

Recruiting

• Conditions: Reconstructive Surgical Procedures

• Registration Number: NCT05736848
• Lead Sponsor: Tela Bio Inc

Brief 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.

Study Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.	24 months	Retrospective - Prospective assessment

Secondary Outcome Measures

Name	Time	Method
Time to Expander/Implant Exchange	24-months	Retrospective - Prospective assessment
Intraoperative Fill Volume / Number and Volume of Fill Visits	24 months	Retrospective - Prospective assessment
Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score	24 months	Image aesthetic assessment
Independent assessment of breast ptosis as measured by the Rainbow Scale	24-months	Retrospective - Prospective assessment
Hospitalization length of stay	At procedure	Retrospective - Prospective assessment

Trial Locations

Locations (11)

Aesthetic Surgery Center; 🇺🇸 Naples, Florida, United States

Castrellon Aesthetic Surgery; 🇺🇸 South Miami, Florida, United States

Capital Health; 🇺🇸 Pennington, New Jersey, 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

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