A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Mammoplasty
Age (in years)
18 - 100
Phase
Not Applicable
Participants needed
100
Est. Completion Date
Mar 30, 2024
Treatment type
Interventional
Sponsor
RTI Surgical
ClinicalTrials.gov identifier
NCT03744013
Study number
CL1104
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