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The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.
This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrolane | Other | Open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrolane | Device | Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment | Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Breasts With Improvement as Assessed by the Investigator | Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS). The scale has five grades ranging from worse to very much improved. Subjects defined as "at least improved" are assessed as improved, much improved or very much improved. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Heden, M.D. | Akademikliniken, Stockholm, Sweden | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20966812 | Result | Heden P, Olenius M, Tengvar M. Macrolane for breast enhancement: 12-month follow-up. Plast Reconstr Surg. 2011 Feb;127(2):850-860. doi: 10.1097/PRS.0b013e318200ae57. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macrolane | Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macrolane | Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment | Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters. | All included participants (Intention To Treat) | Posted | Number | Breasts | 6 weeks | Breasts | Breasts |
|
From day 0 up until 24 months after injection
Systematic assessments:
Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments
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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 | Macrolane | Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Tenderness | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Per Hedén | Akademikliniken, Stockholm, Sweden | +46 8 614 54 00 | per.heden@ak.se |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Breasts |
|
|
| Secondary | Percentage of Breasts With Improvement as Assessed by the Investigator | Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS). The scale has five grades ranging from worse to very much improved. Subjects defined as "at least improved" are assessed as improved, much improved or very much improved. | Intention to treat. Data from 1 participant not available. | Posted | Number | percentage of breasts | 6 weeks | breasts | breasts |
|
|
|
| 0 |
| 24 |
| 18 |
| 24 |
| Capsular contracture associated with breast implant | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Implant site nodule | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Breast discomfort | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
Individual publications shall not be made prior to the first, multi-center publication of the results of the multicenter study. The Investigator shall have the right to publish the results of his work. Any publication or presentation by Institution and/or Principal Investigator shall be submitted to Q Med for review and comment no less than 60 days before submission to allow Q Med to determine whether any patentable invention or Confidential Information would be disclosed.