Macrolane Retrospective Study - Full Text View

Sponsor:	Q-Med AB
Information provided by:	Q-Med AB
ClinicalTrials.gov Identifier:	NCT01223963

Purpose

This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement.

The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.

Condition
Women Who Have Had Breast Enhancement With Macrolane VRF

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement

Further study details as provided by Q-Med AB:

Primary Outcome Measures:

A retrospective chart review to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Volume Restoration Factor 30 when used for female breast enhancement in clinical practice [ Time Frame: 01may2008 - 31dec2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	March 2010
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Macrolane Women that have had breast enhancement with Macrolane Volume Restoration Factor.

Eligibility

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

Study Population

Women that have had breast enhancement in clinics in Sweden (and UK).

Criteria

Inclusion Criteria:

Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement.
Signed Informed Consent

Exclusion Criteria:

Subjects that have actively asked not to be contacted by the clinic
Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223963

Locations

Sweden
Stureplanskliniken
Göteborg, Sweden, 411 05
Akademikliniken
Malmö, Sweden, 217 53
Akademikliniken
Stockholm, Sweden, 115 42
Stureplanskliniken
Stockholm, Sweden, 111 44

Sponsors and Collaborators

Q-Med AB

Investigators

Principal Investigator:

Per Hedén, Md PhD

Akademikliniken

More Information

No publications provided

Responsible Party:	Head of Medical Affairs, Cindy Wong, QMED AB
ClinicalTrials.gov Identifier:	NCT01223963 History of Changes
Other Study ID Numbers:	31GB0902
Study First Received:	October 15, 2010
Last Updated:	October 18, 2010
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Q-Med AB:

Macrolane
Retrospective

ClinicalTrials.gov processed this record on May 23, 2012