Swedish Macrolane Registry

This study is currently recruiting participants.
Verified November 2013 by Q-Med AB
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01145235
First received: June 15, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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


Condition
Breast Augmentation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females previously treated with Macrolane in their breasts.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145235

Contacts
Contact: Frida Nyberg, MSc Frida.nyberg@q-med.com

Locations
Sweden
Dr Per Hedén Recruiting
Stockholm, Sweden
Contact: Per Hedén, MD, PhD       per.heden@ak.se   
Principal Investigator: Per Hedén, MD, PhD         
Sponsors and Collaborators
Q-Med AB
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01145235     History of Changes
Other Study ID Numbers: 31GB0905
Study First Received: June 15, 2010
Last Updated: November 8, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Q-Med AB:
Breast augmentation with Macrolane

ClinicalTrials.gov processed this record on April 17, 2014