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Completed

NCT Number: NCT01639742

European New Texture Implant Clinical Experience With Round Breast Implants

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

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Key information

Conditions

Breast Augmentation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Malteser Krankenhaus, Bonn, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New texture round breast implants

Device

Breast implant surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2017
First posted
Jul 13, 2012
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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