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

RTI Surgical

Status: Completed

Conditions: Mammoplasty

Treatments: Device: Fortiva® 1mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT03744013

CL1104

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Perforated

Active Comparator group

Description:

Fortiva® 1mm perforated ADM

Treatment:

Device: Fortiva® 1mm

Non-perforated

Active Comparator group

Description:

Fortiva® 1mm non-perforated ADM

Treatment:

Device: Fortiva® 1mm