A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis (APPeaR)

A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction

This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.

Study Overview

• Status: Completed
• Conditions: Mammoplasty
• Intervention / Treatment: Device: Fortiva® 1mm

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Frankfurt am Main, Germany, 60590
    • Frankfurt University Hospital
  • München, Germany, 81664
    • University Hospital Technical University, Munich
  • Ulm, Germany, 89081
    • University Hospital, Ulm
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • Manchester, United Kingdom, M23 9LT
    • Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female 18 years or older
2. A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
3. Estimated life expectancy > 2 years
4. Able and willing to return for all scheduled and required study visits
5. Able to provide written informed consent for study participation
6. Able to read, understand and complete study questionnaires

Exclusion Criteria:

1. Any of the conditions listed in the approved labeling as contraindicated
2. Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
3. Any patient that per the physician's judgement is not a good candidate for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perforated; Fortiva® 1mm perforated ADM	Device: Fortiva® 1mm; Post mastectomy immediate reconstruction
Active Comparator: Non-perforated; Fortiva® 1mm non-perforated ADM	Device: Fortiva® 1mm; Post mastectomy immediate reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Fortiva® tissue matrix	Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.	24 months
Performance of Fortiva® tissue matrix	• Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey.	24 months

Collaborators and Investigators

• Sponsor: RTI Surgical

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CL1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No