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

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.

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Key information

Conditions

Mammoplasty

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Agaplesion Markus Krankenhaus, Frankfurt am Main, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fortiva® 1mm

Device

Post mastectomy immediate reconstruction

Primary outcomes

Safety of Fortiva® tissue matrix

Time frame: 24 months

Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
Performance of Fortiva® tissue matrix

Time frame: 24 months
- 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.

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Official study title

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

Acronym: APPeaR

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Nov 16, 2018
Registry last updated: May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed