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NCT01000012 Clinical Trial

Compassionate Use of the Becker Expander/Breast Implant

Breast Reconstruction Clinical Trial

Official title:
Compassionate Use of the Becker Expander/Breast Implant

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01000012
Other study ID # A101-0501-08cu
Secondary ID
Status No longer available
Phase N/A
First received October 21, 2009
Last updated October 28, 2013

Study information
Verified date October 2013
Source Mentor Worldwide, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Device:
• Becker 50 Expander/Breast implant
The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant. The Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc.
• Becker 25 Expander/Breast implant
The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant. The Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc.

Locations
Country Name City State
United States Mentor Worldwide LLC Santa Barbara California

Sponsors (1)
Lead Sponsor Collaborator
Mentor Worldwide, LLC

Country where clinical trial is conducted

United States, 

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