Mammoplasty Clinical Trial
— APPeaROfficial title:
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
NCT number | NCT03744013 |
Other study ID # | CL1104 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2019 |
Est. completion date | January 9, 2024 |
Verified date | May 2024 |
Source | RTI Surgical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | January 9, 2024 |
Est. primary completion date | January 9, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Agaplesion Markus Krankenhaus | Frankfurt am Main | |
Germany | Frankfurt University Hospital | Frankfurt am Main | |
Germany | University Hospital Technical University, Munich | München | |
Germany | University Hospital, Ulm | Ulm | |
United Kingdom | Guy's Hospital | London | |
United Kingdom | Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital | Manchester |
Lead Sponsor | Collaborator |
---|---|
RTI Surgical |
Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Fortiva® tissue matrix | Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events. | 24 months | |
Primary | Performance of Fortiva® tissue matrix | • 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. | 24 months |
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