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Swedish Macrolane Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01145235
First received: June 15, 2010
Last updated: May 9, 2017
Last verified: May 2017
  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 ]

Estimated Enrollment: 2500
Actual Study Start Date: April 2010
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Females previously treated with Macrolane in their breasts.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Locations
Sweden
Dr Per Hedén
Stockholm, Sweden
Sponsors and Collaborators
Q-Med AB
  More Information

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: May 9, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017