At a glance
ClinicalIndex Comparison RecordN/ACompleted· 104 enrolled
Drug / intervention
SeriScaffold® Surgical Scaffolddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
In Brief
A clinical study evaluating SeriScaffold® Surgical Scaffold for Soft Tissue Support and Repair. Completed, enrolled 104 participants across 5 sites in 4 countries.
Detailed Summary
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Support and Repair
CountriesGermany, Italy, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJul 2011
Primary CompletionAug 2013
Study CompletionFeb 2015
TodayJul 2026
First PostedJul 8, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2013
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.0 years ago
Interventions
SeriScaffold® Surgical Scaffolddevice
A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair