Breast ImplantationRANBINCT02132572
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
An observational study of Breast Implantation, run by Allergan at 5 sites in 5 countries.
Trial summary
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Implantation
- What is being tested?
- BIOCELL™ Textured 410 Implant
- Type of treatment
- Medical device
- How many people
- 201 participants
- Where
- 5 sitesin 5 countries
- Study dates
- May 2014to Oct 2014
- Phase
- Observational
- 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
Study population: Subjects that have undergone a primary breast augmentation for aesthetic reasons with a Natrelle BIOCELL™ textured 410 cohesive implant
Who may be able to join
- Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 \& 3 only) has been implanted
- Primary breast augmentation 3 to 10 years prior to data collection
- Submuscular/dual plane or subglandular implant placement
Who cannot join
- Breast augmentation for Poland Syndrome or amastia
- Breast reconstruction following mastectomy
- Revision or secondary breast reconstruction
- Non 410 device at initial breast augmentation
- Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
- Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions)
- Axillary or peri-areolar approach
- Glandular mastopexy augmentation (skin excision only)
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
- Conditions
- Breast Implantation
- Being tested
- BIOCELL™ Textured 410 Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOCELL™ Textured 410 ImplantDevice
Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Natrelle BIOCELL™ Textured 410 Implant | Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. Receives: Device: BIOCELL™ Textured 410 Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant
Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.
Measured: 3 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
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 ImplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132572
- Sponsor's protocol ID
- MAF-AGN-MED-BRE-003
- Acronym
- RANBI
- Status last verified
- Jul 2016
- First submitted
- 6 May 2014
- Last updated
- 13 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)
- ClinicalTrials.gov ID
- NCT02132572
- Acronym / sponsor ID
- RANBI / MAF-AGN-MED-BRE-003
- Conditions
- Breast Implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 13 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natrelle BIOCELL™ Textured 410 Implant | – | Device: BIOCELL™ Textured 410 ImplantPreviously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have undergone a primary breast augmentation for aesthetic reasons with a Natrelle BIOCELL™ textured 410 cohesive implant
Key inclusion criteria (3 listed)
- Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 \& 3 only) has been implanted
- Primary breast augmentation 3 to 10 years prior to data collection
- Submuscular/dual plane or subglandular implant placement
Key exclusion criteria (8 listed)
- Breast augmentation for Poland Syndrome or amastia
- Breast reconstruction following mastectomy
- Revision or secondary breast reconstruction
- Non 410 device at initial breast augmentation
- Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
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 |
|---|---|---|
| BIOCELL™ Textured 410 ImplantPreviously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. | Device | Natrelle BIOCELL™ Textured 410 Implant |
Primary outcome
Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant
Time frame: 3 to 10 years
Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- 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.
Medical Director study director
Allergan
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implantation, run by Allergan at 5 sites in 5 countries.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Israel, Spain, United Kingdom. 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 13 Sep 2016). 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 Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant (time frame: 3 to 10 years). 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 13 Sep 2016.