Skip to main content
OpenTrials
Completed

NCT Number: NCT01223963

Macrolane Retrospective Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Women Who Have Had Breast Enhancement With Macrolane VRF

Sex eligibility

Female

Study type

Observational

Primary location

Stureplanskliniken, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Adverse Events

    Time frame: 01may2008 - 31dec2009

    Number of Adverse events reported during the study period

Other outcomes

  1. Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure

    Time frame: up to 12 months post-procedure

    The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2010
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.