NCT01286870

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2014

Completed
5 years until next milestone

Results Posted

Study results publicly available

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

February 1, 2019

Enrollment Period

4.8 years

First QC Date

January 27, 2011

Results QC Date

November 16, 2018

Last Update Submit

February 12, 2019

Conditions

Breast Reconstruction

Keywords

Primary Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

  • Safety by Incidence, Severity, and Duration of Adverse Events

    4 Years

  • Safety by Method of Resolution of Adverse Events

    4 Years

Study Arms (1)

Reconstruction

OTHER

The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction. The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.

Device: Mentor Becker 25 Expander/Breast ImplantDevice: Mentor Becker 50 Expander/Breast Implant

Interventions

Mentor Becker 25 Expander/Breast ImplantDEVICE

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.

Reconstruction
Mentor Becker 50 Expander/Breast ImplantDEVICE

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.

Reconstruction

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mentor Worldwide LLC

Santa Barbara, California, 93111, United States

Location

MeSH Terms

Interventions

Breast Implants

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Limitations and Caveats

Because only 11 subjects were enrolled in the Becker CA Study, demographic information and key safety information were listed by subject only and no formal summary tables were prepared.

Results Point of Contact

Title
Laura Vellucci
Organization
Mentor Worldwide, LLC
lvelucci@its.jnj.com
(805) 879-6000

Study Officials

  • Mark A. Walker

    Binghamton, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

January 31, 2011

Study Start

June 1, 2009

Primary Completion

March 4, 2014

Study Completion

March 4, 2014

Last Updated

March 6, 2019

Results First Posted

March 6, 2019

Record last verified: 2019-02

Locations

US(1)