The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
NCT ID: NCT01389232
Last Updated: 2021-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2011-06-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SeriScaffold® Surgical Scaffold
Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
SeriScaffold® Surgical Scaffold
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
Interventions
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SeriScaffold® Surgical Scaffold
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
Eligibility Criteria
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Inclusion Criteria
* Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
* Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon
* Be in good health other than breast pathology and be suited to general anesthesia and planned treatments
Exclusion Criteria
* Have a known allergy to silk
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
* Have had a prior soft tissue support device implanted in the breast
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
18 Years
FEMALE
No
Sponsors
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Sofregen Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Düsseldorf, , Germany
Munich, , Germany
Milan, , Italy
Barcelona, , Spain
Nottingham, , United Kingdom
Countries
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Other Identifiers
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SURE-002
Identifier Type: -
Identifier Source: org_study_id
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