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NCT01145235 Clinical Trial

Swedish Macrolane Registry

Breast Augmentation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01145235
Other study ID # 31GB0905
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2010
Est. completion date January 2019

Study information
Verified date August 2018
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.

Recruitment information / eligibility
Status Completed
Enrollment 1300
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1. Females previously treated with Macrolane VRF in the breasts 2. Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment. Exclusion Criteria: No exclusion criteria

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Dr Per Hedén Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2010-2015
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