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Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).
All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments.
The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants in the Pilot study 31GB0601 | Other | This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiological breast examinations - MRI of breast, mammography and ultrasound of breast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiologial breast examination | Radiation | MRI of breast, mammography and ultrasound of breast |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation | The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment. | 7 years +/- 6months post treatment |
| To Evaluate the Long Term Safety of Macrolane in Breast Enhancement | To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation. Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation | 7 years +/- 6 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Hedén, MD, PhD | Akademikliniken, Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akademikliniken Öresund | Malmö | 21753 | Sweden | |||
| Sophiahemmet |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants in the Pilot Study 31GB0601 | This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants in the Pilot Study 31GB0601 | This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiologial breast examination : MRI of breast, mammograophy and ultrasound of 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 | To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation | The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment. | MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI. | Posted | Number | participants with remaining product | 7 years +/- 6months post treatment |
|
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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 | Participants in the Pilot Study 31GB0601 | This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Q-Med AB | +46 (0) 18 4749000 | reception.SEUPP@galderma.com |
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| Stockholm |
| 11486 |
| Sweden |
| Akademikliniken | Stockholm | 11542 | Sweden |
| ProForma Clinic | Stockholm | 118 63 | Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
| Primary | To Evaluate the Long Term Safety of Macrolane in Breast Enhancement | To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation. Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation | Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study. | Posted | Number | participants | 7 years +/- 6 months post treatment |
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| 0 |
| 6 |
| 0 |
| 6 |
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