European New Texture Implant Clinical Experience With Shaped Breast Implants
|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|
|Primary Completion Date :||January 30, 2013|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639755
|Göteburg, Sweden, 41124|
|Stockholm, Sweden, 11542|
|Study Director:||Per Heden||Allergan|