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

Mammoplasty Clinical Trial

— APPeaR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744013
• Other study ID #: CL1104
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: January 9, 2024

Study information

• Verified date: May 2024
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Mammoplasty

Intervention

Device:
• Fortiva® 1mm
Post mastectomy immediate reconstruction

Locations

Country	Name	City	State
Germany	Agaplesion Markus Krankenhaus	Frankfurt am Main
Germany	Frankfurt University Hospital	Frankfurt am Main
Germany	University Hospital Technical University, Munich	München
Germany	University Hospital, Ulm	Ulm
United Kingdom	Guy's Hospital	London
United Kingdom	Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Fortiva® tissue matrix	Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.	24 months
Primary	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