Breast ReconstructionPhase 4NCT01286870

Becker Continued Access Study

A Phase 4 study testing Mentor Becker 25 Expander/Breast Implant and Mentor Becker 50 Expander/Breast Implant in people with Breast Reconstruction, run by Mentor Worldwide, LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Reconstruction
What is being tested?: Mentor Becker 25 Expander/Breast Implant and Mentor Becker 50 Expander/Breast Implant
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2009to 4 Mar 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mentor Worldwide LLC
Santa Barbara, California, 93111

Other trials in United States

About this study

Official title: Continued Access Study of the Mentor Becker Expander/Breast Implant

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.

Read the detailed description

Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Pre-market Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A pre-market approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.

In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision subjects. Every subject implanted had to be part of an adjunct study, in addition to being offered participation in a registry of gel-filled breast implant subjects. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an IDE clinical trial.

A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker Expander/Breast Implants.

The Mentor Becker Expander/Breast Implant was used throughout the United States during this time (since 1992) under the Mentor Adjunct Study to allow continued access to the device and to collect some safety information, however was not evaluated in the MemoryGel Core Study. The gel fill used in the MemoryGel implants is the same gel fill that is used for the Becker device.

This protocol describes the study design procedures and population for a Continued Access (CA) Study for the Mentor Becker 25 and 50 Expander/Breast implants. While Core Becker patient follow-up is being completed, this CA Study is designed to enroll patients at a limited rate per month to allow for continued physician experience with the device. The safety data obtained may be used to provide supplemental information to the PMA. It will be requested that this study be initiated and renewed every six months until a final decision is reached regarding the Becker PMA.

Conditions: Breast Reconstruction
Being tested: Mentor Becker 25 Expander/Breast Implant, Mentor Becker 50 Expander/Breast Implant
Keywords: Primary Breast Reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT01286870
Study group	Role	What they receive
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. Receives: Device: Mentor Becker 25 Expander/Breast Implant; Device: Mentor Becker 50 Expander/Breast Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety by Incidence, Severity, and Duration of Adverse Events
Measured: 4 Years
Safety by Method of Resolution of Adverse Events
Measured: 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20094 Mar 2014

First posted31 Jan 2011 (estimated)
Study start1 Jun 2009
Primary completion4 Mar 2014
Study completion4 Mar 2014

Why it stopped: Sponsor terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast ReconstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286870
Sponsor's protocol ID: 1222CA-1208-01
Other IDs: Becker CA Study
Status last verified: Feb 2019
First submitted: 27 Jan 2011
Last updated: 6 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Reconstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Continued Access Study of the Mentor Becker Expander/Breast Implant
ClinicalTrials.gov ID: NCT01286870
Acronym / sponsor ID: 1222CA-1208-01
Conditions: Breast Reconstruction
Keywords: Primary Breast Reconstruction
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor terminated
Enrolment: 11 participants (actual)
Lead sponsor: Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
Study start: 1 Jun 2009 (actual)
Primary completion: 4 Mar 2014 (actual)
Study completion: 4 Mar 2014 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 6 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Reconstruction	Other	Device: Mentor Becker 25 Expander/Breast Implant, Device: Mentor Becker 50 Expander/Breast ImplantThe 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mentor Becker 25 Expander/Breast ImplantThe 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.	Device	Reconstruction
Mentor Becker 50 Expander/Breast ImplantThe 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.	Device	Reconstruction

Primary outcome

Safety by Incidence, Severity, and Duration of Adverse Events
Time frame: 4 Years
Safety by Method of Resolution of Adverse Events
Time frame: 4 Years

Results and safety

Results posted to the registry on 6 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reconstruction	11	11

Primary outcome: Safety by Incidence, Severity, and Duration of Adverse Events

Time frame: 4 Years. Number. Unit: Events

Measure	Reconstruction n = 11
Number of Adverse Events (AEs)	33
Mild AEs	32
Moderate AEs	1
Severe AEs	0
Ongoing AEs at end of trial	6
Resolved AEs	27
AE resolution the same day as AE onset	5
AE resolution in 1 week (1-7 days)	12

Population analysed: The study was prematurely discontinued. The sample size was not large enough for statistical significance. 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.

Primary outcome: Safety by Method of Resolution of Adverse Events

Time frame: 4 Years. Number. Unit: Procedures

Measure	Reconstruction n = 11
Re-operation Procedures Without Explantation	16
Re-operation Procedures With Explantation	9

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reconstruction	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Reconstruction

RecruitingPhase 1
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Not yet recruiting
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
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Active, not recruitingObservational study
Autologous Nerve Graft Breast Reconstruction Neurotization
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark A. Walker principal investigator

Binghamton, NY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety by Incidence, Severity, and Duration of Adverse Events (time frame: 4 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01286870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.