NCT01223963

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

March 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

December 15, 2017

Completed
Last Updated

August 26, 2022

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

October 15, 2010

Results QC Date

March 14, 2014

Last Update Submit

August 24, 2022

Conditions

Women Who Have Had Breast Enhancement With Macrolane VRF

Keywords

MacrolaneRetrospective

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    Number of Adverse events reported during the study period

    01may2008 - 31dec2009

Other Outcomes (1)

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

    up to 12 months post-procedure

Study Arms (1)

Macrolane

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stureplanskliniken

Gothenburg, 411 05, Sweden

Location

Akademikliniken

Malmo, 217 53, Sweden

Location

Stureplanskliniken

Stockholm, 111 44, Sweden

Location

Akademikliniken

Stockholm, 115 42, Sweden

Location

Results Point of Contact

Title
Chief Medical Officer
Organization
Q-Med AB
reception.seupp@galderma.com
+46 18 4749000

Study Officials

  • Per Hedén, Md PhD

    Akademikliniken

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 19, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 26, 2022

Results First Posted

December 15, 2017

Record last verified: 2012-11

Locations

SE(4)