Swedish Macrolane Registry

August 24, 2022 updated by: Galderma R&D
A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Dr Per Hedén

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All clinics treating females with Macrolane in the breast will be asked to participate.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Females previously treated with Macrolane in their breasts.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 2010-2015
2010-2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 31GB0905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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