Swedish Macrolane Registry

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014