A Retrospective Assessment of OviTex PRS (OviTex)

Reconstructive Surgical Procedures Clinical Trial

— PRS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736848
• Other study ID #: TB2022.01.02
• Status: Recruiting
• Start date: September 27, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Tela Bio Inc
• Contact: Zachary Sterner
• Phone: 937-514-2262
• Email: zsterner[@]telabio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patient was between 18 years and 70 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 is 6-months or more post initial surgical procedure.

Exclusion Criteria:

1. Patient received a textured expander or implant.

2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.

3. Patient was marijuana user (including smokeless, vaporized, etc.) within 4-weeks preceding their index procedure.

4. 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.

Related Conditions & MeSH terms

• Reconstructive Surgical Procedures

Intervention

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

Country	Name	City	State
United States	Y Plastic Surgery	Alpharetta	Georgia
United States	Plastic Surgery Consultants	Columbia	South Carolina
United States	Stong Memorial Hospital	Rochester	New York
United States	Janineh Plastic Surgery	Rochester Hills	Michigan
United States	Dermatology Associates of San Antonio/Baptist Medical Center	San Antonio	Texas
United States	Houston Methodist The Woodlands Hospita	The Woodlands	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Tela Bio Inc	MCRA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.	Retrospective - Prospective assessment	24 months
Primary	Narcotic usage	Retrospective - Prospective assessment	24 months
Primary	Hospitalization length of stay	Retrospective - Prospective assessment	At procedure
Secondary	Time to Expander/Implant Exchange	Retrospective - Prospective assessment	24-months
Secondary	Intraoperative Fill Volume / Number and Volume of Fill Visits	Retrospective - Prospective assessment	24 months
Secondary	Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score	Image aesthetic assessment	24 months
Secondary	Independent assessment of breast ptosis as measured by the Rainbow Scale	Retrospective - Prospective assessment	24-months