Women Who Have Had Breast Enhancement With Macrolane VRF Clinical Trial
Official title:
A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement
| NCT number | NCT01223963 |
| Other study ID # | 31GB0902 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2010 |
| Est. completion date | July 2010 |
| Verified date | November 2012 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement. The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | July 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement. - Signed Informed Consent Exclusion Criteria: - Subjects that have actively asked not to be contacted by the clinic - Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Stureplanskliniken | Göteborg | |
| Sweden | Akademikliniken | Malmö | |
| Sweden | Akademikliniken | Stockholm | |
| Sweden | Stureplanskliniken | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure | The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated. | up to 12 months post-procedure | |
| Primary | Number of Adverse Events | Number of Adverse events reported during the study period | 01may2008 - 31dec2009 |