Swedish Macrolane Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01145235

Enrollment

1300

Registered

2010-06-16

Start date

2010-04-30

Completion date

2019-01-31

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation

Keywords

Breast augmentation with Macrolane

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Sweden

Outcome results