Status:
COMPLETED
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
Lead Sponsor:
Sofregen Medical, Inc.
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
Eligibility Criteria
Inclusion
- To be eligible for enrollment, the subject must:
- Be female, greater or equal to 18 years of age
- Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
- Have previously had or 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
- The subject must not:
- Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
- Have a known allergy to silk
- Have collagen-vascular, connective disease, or bleeding disorders
- Have a Body Mass Index (BMI) that is greater than or equal to 35
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer
- Have smoked within the last 12 months
- Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
- Be pregnant, lactating, or expecting to be within the next 24 months
- Have concomitant unrelated condition of breast/chest wall/skin
- Have an abscess or infection at the time of surgery
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01256502
Start Date
October 1 2010
End Date
April 1 2014
Last Update
November 6 2017
Active Locations (1)
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1
Los Angeles, California, United States