Swedish Macrolane Registry

Completed

• Conditions: Breast Augmentation

• Registration Number: NCT01145235
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Status Verified: 2018-08
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr Per Hedén; 🇸🇪 Stockholm, Sweden