The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

Completed · Not applicable

Conditions studied: Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT01256502

Run by

Sofregen Medical, Inc.

People needed

160

Starts

2010-10-01

Expected to finish

2014-04-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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