European New Texture Implant Clinical Experience With Shaped Breast Implants

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Allergan Identifier:
First received: July 11, 2012
Last updated: July 2, 2015
Last verified: July 2015
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.

Condition Intervention
Breast Augmentation
Device: new texture shaped breast implants

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Investigator Overall Satisfaction With the Device Using a 5-Point Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale [ Time Frame: Interim analysis: 12 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Local Complications [ Time Frame: Interim analysis: 12 months ] [ Designated as safety issue: Yes ]
    The percentage of participants experiencing local complications (in the area of the implant) is reported.

Enrollment: 19
Study Start Date: June 2012
Estimated Study Completion Date: October 2017
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants
Al participants who had new texture shaped breast implants surgically implanted.
Device: new texture shaped breast implants
breast implant surgery


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01639755

Stockholm, Sweden
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan Identifier: NCT01639755     History of Changes
Other Study ID Numbers: ENTICE-002 
Study First Received: July 11, 2012
Results First Received: July 2, 2015
Last Updated: July 2, 2015
Health Authority: Sweden: Regional Ethical Review Board processed this record on May 26, 2016