Becker Continued Access Study

Stopped early · Phase 4

Conditions studied: Breast Reconstruction

In brief

While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device. Up to 12 patients per month at sites across the United States will be enrolled in this research study. These patients will be implanted with the Becker 25 or Becker 50 Expander/Breast implant and monitored for 10 years for safety.

Key facts

Study ID

NCT01286870

Run by

Mentor Worldwide, LLC

People needed

11

Starts

2009-06-01

Expected to finish

2014-03-04

Last updated by the study team

2019-03-06

Who can join

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

You may qualify if…

• Subject is genetic female, 18 years of age or older
• A candidate for primary breast reconstruction for cancer, trauma, surgical loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, or congenital deformity, including asymmetry (see Section 6.0 for definition)
• Signs the Informed Consent
• Agrees to return device to Mentor if explant necessary
• Agrees to comply with follow-up procedures, including returning for all follow-up visits
• Patient is a US citizen with a Social Security Number and understands English

You may not qualify if…

• Subject is pregnant
• Has nursed a child within three months of study enrollment.
• Been implanted with any silicone implant including breast implants (e.g. silicone artificial joints or facial implants)
• Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondylarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
• Infection or abscess anywhere in the body
• Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
• Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
• Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
• Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
• Premalignant breast disease without a subcutaneous mastectomy
• Untreated or inappropriately treated breast malignancy, without mastectomy
• Are HIV positive
• Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive
• Physician is intending to use the device for tissue expansion only

Where it is running

• Mentor Worldwide LLC — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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