Macrolane Retrospective Study
August 24, 2022 updated by: Galderma R&D
A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
93
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Göteborg, Sweden, 411 05
- Stureplanskliniken
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Malmö, Sweden, 217 53
- Akademikliniken
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Stockholm, Sweden, 115 42
- Akademikliniken
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Stockholm, Sweden, 111 44
- Stureplanskliniken
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women that have had breast enhancement in clinics in Sweden (and UK).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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Macrolane
Women that have had breast enhancement with Macrolane Volume Restoration Factor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Adverse Events
Time Frame: 01may2008 - 31dec2009
|
Number of Adverse events reported during the study period
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01may2008 - 31dec2009
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure
Time Frame: up to 12 months 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.
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up to 12 months post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Per Hedén, Md PhD, Akademikliniken
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
October 15, 2010
First Submitted That Met QC Criteria
October 18, 2010
First Posted (Estimate)
October 19, 2010
Study Record Updates
Last Update Posted (Actual)
August 26, 2022
Last Update Submitted That Met QC Criteria
August 24, 2022
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 31GB0902
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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