An interventional study of Fortiva® 1mm in Mammoplasty, sponsored by RTI Surgical. Completed at 6 sites in 2 countries. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by RTI Surgical · Not applicable, Interventional, and Treatment
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.
RTI Surgical is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fortiva® 1mm perforated ADM
Device: Fortiva® 1mm
Fortiva® 1mm non-perforated ADM
Device: Fortiva® 1mm
Post mastectomy immediate reconstruction
Safety of Fortiva® tissue matrix
Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
Time frame: 24 months
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.
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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