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European New Texture Implant Clinical Experience With Shaped Breast Implants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01639755
First received: July 11, 2012
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.

Condition Intervention Phase
Breast Augmentation Device: new texture shaped breast implants Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other

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: 19
Actual Study Start Date: June 18, 2012
Estimated Study Completion Date: October 1, 2017
Primary Completion Date: January 30, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants
Al participants who had new texture shaped breast implants surgically implanted.
Device: new texture shaped breast implants
breast implant surgery

  Eligibility

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
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: NCT01639755

Locations
Sweden
Klinik 34
Göteburg, Sweden, 41124
Akademikliniken 10
Stockholm, Sweden, 11542
Sponsors and Collaborators
Allergan
Investigators
Study Director: Per Heden Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01639755     History of Changes
Other Study ID Numbers: ENTICE-002
Study First Received: July 11, 2012
Results First Received: July 2, 2015
Last Updated: May 17, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017