Mammoplasty
Conditions
Brief 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.
Interventions
DEVICEFortiva® 1mm
Post mastectomy immediate reconstruction
Sponsors
RTI Surgical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
post market prospective, multi-center study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Fortiva® tissue matrix | 24 months | Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events. |
| Performance of Fortiva® tissue matrix | 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. |
Countries
Germany, United Kingdom
Outcome results
None listed