European New Texture Implant Clinical Experience With Round Breast Implants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01639742

Enrollment

Registered

2012-07-13

Start date

2012-06-18

Completion date

2017-10-12

Last updated

2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation

Brief summary

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

Interventions

DEVICENew texture round breast implants

Breast implant surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Investigator Overall Satisfaction With the Device Using a 5-Point Scale	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

Measure	Time frame	Description
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire	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.
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue	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.
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale	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.
Percentage of Participants With Local Complications	Interim analysis: 12 months	The percentage of participants experiencing local complications (in the area of the implant) is reported.

Countries

Germany, Sweden, United Kingdom

Participant flow

Participants by arm

Arm	Count
All Participants All participants who had new texture round breast implants surgically implanted.	18
Total	18

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1
Overall Study	Study Ongoing	17

Baseline characteristics

Characteristic	All Participants
Age, Continuous	31.9 years STANDARD_DEVIATION 8.89
Sex: Female, Male Female	18 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	18 / 18
serious Total, serious adverse events	2 / 18

Outcome results

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.

Time frame: 3 months