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Clinical Trials/NCT01639742
NCT01639742CompletedNot Applicable

European New Texture Implant Clinical Experience With Round Breast Implants

Allergan4 sites in 3 countries18 target enrollmentStarted: June 18, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Allergan
Enrollment
18
Locations
4
Primary Endpoint
Investigator Overall Satisfaction With the Device Using a 5-Point Scale
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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

Arms & Interventions

All Participants

Experimental

All participants who had new texture round breast implants surgically implanted.

Intervention: New texture round breast implants (Device)

Outcomes

Primary Outcomes

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

  • Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire(6 months)
  • Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue(6 months)
  • Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale(Interim analysis: 12 months)
  • Percentage of Participants With Local Complications(Interim analysis: 12 months)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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