Swedish Macrolane Registry

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

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Key information

Conditions

Breast Augmentation

Sex eligibility

Female

Study type

Observational

Primary location

Dr Per Hedén

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2019
Study completion: 2019
First posted: Jun 16, 2010
Registry last updated: Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed