Breast AugmentationNCT01785069
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
A study testing Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection in people with Breast Augmentation and Breast Reconstruction, run by Allergan at 29 sites in United States.
Trial summary
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- What is being tested?
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 29 sitesUnited States
- Study dates
- 10 Dec 2012to 30 Nov 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants
- Female, age 18 or older
- Present with 1 or more of the following conditions:
- Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
- Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast)
- Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
- Has adequate tissue available to cover implants
- Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)
Who cannot join
- For entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery
- Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Does not have existing carcinoma of the breast, without mastectomy
- Does not have abscess or infection in the body at the time of enrollment
- Is not pregnant or nursing
- Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability
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- Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration
- Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
- Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
- Is not willing to undergo further surgery for revision, if medically required
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Walter Erhardt
Albany, Georgia, 31701
James Namnoum
Atlanta, Georgia, 30342
Peter Hyans
Berkeley Heights, New Jersey, 07922
Laurence Berkowitz
Campbell, California, 95008
Janet Turkle
Carmel, Indiana, 46032
Charles Nathan
Chesterfield, Missouri, 63005
Herluf Jr. Lund
Chesterfield, Missouri, 63005
Raymond Isakov
Cleveland, Ohio, 44195
Gregory Liebscher
Colorado Springs, Colorado, 80919
Patricia McGuire
Creve Coeur, Missouri, 63141
John Renucci
Grand Rapids, Michigan, 49503
Tracy Pfeifer
Great Neck, New York, 10028
Jeffrey Friedman
Houston, Texas, 77030
Peter Hetzler
Little Silver, New Jersey, 07739
Julene Samuels
Louisville, Kentucky, 40205
Steven Morris
Midland, Michigan, 48640
Timothy Mickel
Monroe, Louisiana, 71201
Mary Gingrass
Nashville, Tennessee, 37203
Patrick Maxwell
Nashville, Tennessee, 37212
Lloyd Gayle
New York, New York, 10021
Thomas Blanchard
Newport News, Virginia, 23606
Perry Johnson
Omaha, Nebraska, 68118
Calvin Peters
Orlando, Florida, 32801
Roy Hong
Palo Alto, California, 94301
Eric Bachelor
Pleasanton, California, 94566
Caroline Glicksman
Sea Girt, New Jersey, 08750
Craig Colville
Toledo, Ohio, 43615
Frank Barone
Toledo, Ohio, 43623
Scott Spear
Washington D.C., District of Columbia, 20007
About this study
Official title: A Prospective Multicenter Study of the Safety and Effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-filled X-style and L-style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Being tested
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomically shaped, silicone-filled breast implants with low projection or extra-full projectionDevice
Also called NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Surgical implant
| Study group | Role | What they receive |
|---|---|---|
| Augmentation | Experimental | Women who had breast augmentation with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection |
| Reconstruction | Experimental | Women who had breast reconstruction with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection |
| Revision-Augmentation | Experimental | Women who had revision of a previous breast augmentation with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection |
| Revision-Reconstruction | Experimental | Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants According to Investigator Satisfaction With Implants
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Measured: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants According to Participant Satisfaction With Implants
The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Measured: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Secondary outcomes (3)
Percentage of Participants With Local Complications
Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast Pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Implant malposition, Implant palpability/visibility. Implant rupture, Infection, Ptosis, Redness, Swelling, Wrinkling/rippling and Other complications (calcifications on mammogram, thing of mastectomy flap, deformity and nipple stretching).
Measured: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants With Reoperations
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Measured: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants With Implant Removal With or Without Replacement
Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement
Measured: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study start10 Dec 2012
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Why it stopped: There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.
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 AugmentationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Schumacher, Study chair, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785069
- Sponsor's protocol ID
- 410XL-001
- Status last verified
- Jun 2020
- First submitted
- 14 Jan 2013
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of the Safety and Effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-filled X-style and L-style Breast Implants
- ClinicalTrials.gov ID
- NCT01785069
- Acronym / sponsor ID
- 410XL-001
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.
- Enrolment
- 355 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2012 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Augmentation | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projectionWomen who had breast augmentation with NATRELLE® 410 implants. |
| Reconstruction | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projectionWomen who had breast reconstruction with NATRELLE® 410 implants. |
| Revision-Augmentation | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projectionWomen who had revision of a previous breast augmentation with NATRELLE® 410 implants. |
| Revision-Reconstruction | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projectionWomen who had revision of a previous breast reconstruction with NATRELLE® 410 implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants
- Female, age 18 or older
- Present with 1 or more of the following conditions:
- Has adequate tissue available to cover implants
- Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)
Key exclusion criteria (10 listed)
- For entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery
- Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Does not have existing carcinoma of the breast, without mastectomy
- Does not have abscess or infection in the body at the time of enrollment
- Is not pregnant or nursing
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 |
|---|---|---|
| Anatomically shaped, silicone-filled breast implants with low projection or extra-full projectionAlso: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast ImplantsSurgical implant | Device | Augmentation, Reconstruction, Revision-Augmentation, Revision-Reconstruction |
Primary outcome
Percentage of Participants According to Investigator Satisfaction With Implants
Time frame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Percentage of Participants According to Participant Satisfaction With Implants
Time frame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
3 secondary outcomes
Percentage of Participants With Local Complications
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants With Reoperations
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants With Implant Removal With or Without Replacement
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Schumacher study chair
Allergan
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection in people with Breast Augmentation and Breast Reconstruction, run by Allergan at 29 sites in United States.
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 8 inclusion and 10 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2020). 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?
Percentage of Participants According to Investigator Satisfaction With Implants (time frame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)). 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?
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 25 Jun 2020.