For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

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
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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.
Phone iconCall 952-698-9926Email iconEmail Study Center

Study’s details


Contition

Mammoplasty

Age (in years)

18 - 100

Phase

N/A

Participants needed

100

Est. Completion Date

Mar 2024

Treatment type

Interventional


Sponsor

RTI Surgical

ClinicalTrials.gov identifier

NCT03744013

Study number

CL1104

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