NCT01145235

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2018

Enrollment Period

8.8 years

First QC Date

June 15, 2010

Last Update Submit

August 24, 2022

Conditions

Breast Augmentation

Keywords

Breast augmentation with Macrolane

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Females previously treated with Macrolane in their breasts.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Females previously treated with Macrolane VRF in the breasts
  • Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Per Hedén

Stockholm, Sweden

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 25, 2022

Record last verified: 2018-08

Locations

SE(1)