European New Texture Implant Clinical Experience With Shaped Breast Implants

The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.

Study Overview

• Status: Completed
• Conditions: Breast Augmentation
• Intervention / Treatment: Device: new texture shaped breast implants

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Göteburg, Sweden, 41124
    • Klinik 34
  • Stockholm, Sweden, 11542
    • Akademikliniken 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Interim analysis: 12 months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Per Heden, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2012
• Primary Completion (Actual): January 30, 2013
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ENTICE-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No