Compassionate Use of the Becker Expander/Breast Implant
- Conditions
- Breast Reconstruction
- Registration Number
- NCT01000012
- Lead Sponsor
- Mentor Worldwide, LLC
- Brief Summary
To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study
Patients' physician will contact Mentor to request use of the device and each request will be reviewed by Mentor, an IRB, and the FDA on a case-by-case basis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study
Exclusion Criteria
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mentor Worldwide LLC
🇺🇸Santa Barbara, California, United States
Mentor Worldwide LLC🇺🇸Santa Barbara, California, United States