European New Texture Implant Clinical Experience With Shaped Breast Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01639755
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : July 29, 2015
Last Update Posted : November 30, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Augmentation Device: new texture shaped breast implants Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: European New Texture Implant Clinical Experience With Shaped Breast Implants
Actual Study Start Date : June 18, 2012
Actual Primary Completion Date : January 30, 2013
Actual Study Completion Date : October 16, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: All Participants
Al participants who had new texture shaped breast implants surgically implanted.
Device: new texture shaped breast implants
breast implant surgery

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire [ Time Frame: 6 months ]
    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.

  2. Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue [ Time Frame: 6 months ]
    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.

  3. Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale [ Time Frame: Interim analysis: 12 months ]
    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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01639755

Klinik 34
Göteburg, Sweden, 41124
Akademikliniken 10
Stockholm, Sweden, 11542
Sponsors and Collaborators
Study Director: Per Heden Allergan

Responsible Party: Allergan Identifier: NCT01639755     History of Changes
Other Study ID Numbers: ENTICE-002
First Posted: July 13, 2012    Key Record Dates
Results First Posted: July 29, 2015
Last Update Posted: November 30, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No