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The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | Al participants who had new texture shaped breast implants surgically implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new texture shaped breast implants | Device | breast implant surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Overall Satisfaction With the Device Using a 5-Point Scale | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | 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. | 6 months |
| Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Heden | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik 34 | Göteburg | 41124 | Sweden | |||
| Akademikliniken 10 |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Al participants who had new texture shaped breast implants surgically implanted. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Al participants who had new texture shaped breast implants surgically implanted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Overall Satisfaction With the Device Using a 5-Point Scale | 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. | Full analysis population included all participants. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Al participants who had new texture shaped breast implants surgically implanted. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device dislocation | General disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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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. |
| 6 months |
| Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | 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. | Interim analysis: 12 months |
| Percentage of Participants With Local Complications | The percentage of participants experiencing local complications (in the area of the implant) is reported. | Interim analysis: 12 months |
| Stockholm |
| 11542 |
| Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | 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. | Full analysis population included all participants. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue | 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. | Full analysis population included all participants. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | 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. | Participants from the Full Analysis population with data available for analysis. | Posted | Number | percentage of participants | Interim analysis: 12 months |
|
|
|
| Secondary | Percentage of Participants With Local Complications | The percentage of participants experiencing local complications (in the area of the implant) is reported. | Full analysis population included all participants. | Posted | Number | percentage of participants | Interim analysis: 12 months |
|
|
|
| 2 |
| 19 |
| 19 |
| 19 |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Breast complication associated with device | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Helicobacter gastritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Nervous system disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
|
| Baker Grade IV |
|