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European New Texture Implant Clinical Experience With Round Breast Implants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639742
First Posted: July 13, 2012
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.

Condition Intervention
Breast Augmentation Device: New texture round breast implants

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: European New Texture Implant Clinical Experience With Round Breast Implants

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 18
Actual Study Start Date: June 18, 2012
Study Completion Date: October 12, 2017
Primary Completion Date: January 30, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants
All participants who had new texture round breast implants surgically implanted.
Device: New texture round breast implants
Breast implant surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639742


Locations
Germany
Praxisklinik Siepe Friedrichstraße 57
Bonn, Germany, 53111
Malteser Krankenhaus
Bonn, Germany, 53123
Sweden
Akademikliniken 10
Stockholm, Sweden, 11542
United Kingdom
Dolan Park Hospital
Birmingham, United Kingdom, B60 1LY
Sponsors and Collaborators
Allergan
Investigators
Study Director: Per Heden Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01639742     History of Changes
Other Study ID Numbers: ENTICE-001
First Submitted: July 11, 2012
First Posted: July 13, 2012
Results First Submitted: July 2, 2015
Results First Posted: July 29, 2015
Last Update Posted: November 30, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No