NCT01223066

Brief Summary

The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

August 25, 2022

Status Verified

November 1, 2012

Enrollment Period

1 month

First QC Date

October 15, 2010

Last Update Submit

August 24, 2022

Conditions

Females Recently Treated With Macrolane VRF in the Breasts

Keywords

Macrolane

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    up to 5 years

Study Arms (1)

Women treated with Macrolane in the breasts

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating clinics will ask women who have been treated with Macrolane in the breasts in clinical practice, to participate in this survey.

You may qualify if:

  • Females recently treated with Macrolane Volume Restoration Factor in the breasts.
  • Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademikliniken

Stockholm, 115 42, Sweden

Location

Study Officials

  • Per Hedén, Md PhD

    Akademikliniken Stockholm

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 25, 2022

Record last verified: 2012-11

Locations

SE(1)