European New Texture Implant Clinical Experience With Round Breast Implants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01639742
First received: July 11, 2012
Last updated: April 27, 2015
Last verified: April 2015
  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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Investigator's overall satisfaction with the device will be evaluated using a 5-point scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject satisfaction with breasts will be measured using the BREAST-Q questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Investigator evaluation of whether the implant is palpably distinguishable from the tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Presence of capsular contracture evaluated on a 5-Point Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Local complications evaluated by Four-grade Baker Scale [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: June 2012
Estimated Study Completion Date: September 2018
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: New texture round breast implants
Breast implant surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639742

Locations
Germany
Bonn, Germany
Sweden
Stockholm, Sweden
United Kingdom
Bromsgrove, United Kingdom
Sponsors and Collaborators
Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01639742     History of Changes
Other Study ID Numbers: ENTICE-001
Study First Received: July 11, 2012
Last Updated: April 27, 2015
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on July 27, 2015