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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01639755
Other study ID # ENTICE-002
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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