European New Texture Implant Clinical Experience With Shaped Breast Implants

Breast Augmentation Clinical Trial

Official title:

European New Texture Implant Clinical Experience With Shaped Breast Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639755
• Other study ID #: ENTICE-002
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2012
• Last updated: October 26, 2017
• Start date: June 18, 2012
• Est. completion date: October 16, 2017

Study information

• Verified date: October 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 16, 2017
• Est. primary completion date: January 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Augmentation

Intervention

Device:
• new texture shaped breast implants
breast implant surgery

Locations

Country	Name	City	State
Sweden	Klinik 34	Göteburg
Sweden	Akademikliniken 10	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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