Swedish Macrolane Registry
This study is currently recruiting participants.
Verified November 2012 by Q-Med AB
Sponsor:
Q-Med AB
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01145235
First received: June 15, 2010
Last updated: November 22, 2012
Last verified: November 2012
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Purpose
A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.
| Condition |
|---|
|
Breast Augmentation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Further study details as provided by Q-Med AB:
Primary Outcome Measures:
- To document the incidence of breast cancer in female subjects after treatment with Macrolane VRFs in the breasts when the product is used in clinical practice. [ Time Frame: 2010-2015 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | April 2010 |
| Groups/Cohorts |
|---|
| Females previously treated with Macrolane in their breasts. |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
All clinics treating females with Macrolane in the breast will be asked to participate.
Criteria
Inclusion Criteria:
- Females previously treated with Macrolane VRF in the breasts
- Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment.
Exclusion Criteria:
No exclusion criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145235
Contacts
| Contact: Frida Nyberg, MSc | Frida.nyberg@q-med.com |
Locations
| Sweden | |
| Dr Per Hedén | Recruiting |
| Stockholm, Sweden | |
| Contact: Per Hedén, MD, PhD per.heden@ak.se | |
| Principal Investigator: Per Hedén, MD, PhD | |
Sponsors and Collaborators
Q-Med AB
More Information
No publications provided
| Responsible Party: | Q-Med AB |
| ClinicalTrials.gov Identifier: | NCT01145235 History of Changes |
| Other Study ID Numbers: | 31GB0905 |
| Study First Received: | June 15, 2010 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Q-Med AB:
|
Breast augmentation with Macrolane |
ClinicalTrials.gov processed this record on May 16, 2013