Clinical Trials Logo
  1. Home
  2. Breast Reconstruction
  3. NCT01000012
  4. Details
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, 

See also
  Status Clinical Trial Phase
Recruiting NCT03757793 - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed NCT05491473 - Negative Pressure in PAP Donor Sites
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed NCT02169011 - Secondary Breast Reconstruction With a Flap of Skin From the Back N/A
Completed NCT01216319 - Evaluation of the Cook Biodesign Plastic Surgery Matrix N/A
Not yet recruiting NCT00973544 - Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis? N/A
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Active, not recruiting NCT00748722 - Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography N/A
Completed NCT00753922 - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses Phase 3
Completed NCT05897463 - Nipple Neurotization
Recruiting NCT05377723 - Abdominal Scar Improvement in Microsurgical Breast Reconstruction N/A
Completed NCT04350411 - Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction N/A
Completed NCT06321549 - New Era of DIEP With Minimally Invasive Mastectomy
Withdrawn NCT03135392 - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer N/A
Completed NCT01256502 - The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery N/A
Active, not recruiting NCT04715802 - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Active, not recruiting NCT04491591 - Implementing BREASTChoice Into Practice N/A
Recruiting NCT04661501 - BREAST ADM Trial for Alloplastic Breast Reconstruction N/A
Suspended NCT03625765 - Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye N/A
Withdrawn NCT00778947 - Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction N/A