Breast AugmentationNCT01639742
European New Texture Implant Clinical Experience With Round Breast Implants
A study testing New texture round breast implants in people with Breast Augmentation, run by Allergan at 4 sites in 3 countries.
Trial summary
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation. 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
- What is being tested?
- New texture round breast implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 18 Jun 2012to 12 Oct 2017
- 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
- Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
- Be a candidate for the device styles and sizes available in the study
Who cannot join
- Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
- Have undergone any previous breast surgery
- Have tissue covering determined inadequate or unsuitable by the surgeon
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Praxisklinik Siepe Friedrichstraße 57
Bonn, 53111
Malteser Krankenhaus
Bonn, 53123
About this study
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
- Conditions
- Breast Augmentation
- Being tested
- New texture round breast implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New texture round breast implantsDevice
Breast implant surgery
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All participants who had new texture round breast implants surgically implanted. Receives: Device: New texture round breast implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Overall Satisfaction With the Device Using a 5-Point Scale
The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Measured: 3 months
Secondary outcomes (4)
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire
Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.
Measured: 6 months
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue
The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.
Measured: 6 months
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale
The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.
Measured: Interim analysis: 12 months
Percentage of Participants With Local Complications
The percentage of participants experiencing local complications (in the area of the implant) is reported.
Measured: Interim analysis: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study start18 Jun 2012
- Primary completion30 Jan 2013
- Study completion12 Oct 2017
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Heden, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639742
- Sponsor's protocol ID
- ENTICE-001
- Status last verified
- Oct 2017
- First submitted
- 11 Jul 2012
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European New Texture Implant Clinical Experience With Round Breast Implants
- ClinicalTrials.gov ID
- NCT01639742
- Acronym / sponsor ID
- ENTICE-001
- Conditions
- Breast Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2012 (actual)
- Primary completion
- 30 Jan 2013 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 29 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: New texture round breast implantsAll participants who had new texture round breast implants surgically implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
- Be a candidate for the device styles and sizes available in the study
Key exclusion criteria (3 listed)
- Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
- Have undergone any previous breast surgery
- Have tissue covering determined inadequate or unsuitable by the surgeon
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 |
|---|---|---|
| New texture round breast implantsBreast implant surgery | Device | All Participants |
Primary outcome
Investigator Overall Satisfaction With the Device Using a 5-Point Scale
Time frame: 3 months
The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
4 secondary outcomes
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire
Time frame: 6 months
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue
Time frame: 6 months
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale
Time frame: Interim analysis: 12 months
Percentage of Participants With Local Complications
Time frame: Interim analysis: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- 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.
Per Heden study director
Allergan
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New texture round breast implants in people with Breast Augmentation, run by Allergan at 4 sites in 3 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 2 inclusion and 3 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Sweden, 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 29 Jul 2015). 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?
Investigator Overall Satisfaction With the Device Using a 5-Point Scale (time frame: 3 months). 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 30 Nov 2017.