European New Texture Implant Clinical Experience With Shaped Breast Implants
|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.|
|ClinicalTrials.gov Identifier: NCT01639755|
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : July 29, 2015
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Augmentation||Device: new texture shaped breast implants||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||European New Texture Implant Clinical Experience With Shaped Breast Implants|
|Actual Study Start Date :||June 18, 2012|
|Actual Primary Completion Date :||January 30, 2013|
|Actual Study Completion Date :||October 16, 2017|
Experimental: All Participants
Al participants who had new texture shaped breast implants surgically implanted.
Device: new texture shaped breast implants
breast implant surgery
- 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.
- 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.
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): NCT01639755
|Göteburg, Sweden, 41124|
|Stockholm, Sweden, 11542|
|Study Director:||Per Heden||Allergan|