Macrolane Retrospective Study

NCT ID: NCT01223963

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Women Who Have Had Breast Enhancement With Macrolane VRF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Macrolane

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Hedén, Md PhD

Role: PRINCIPAL_INVESTIGATOR

Akademikliniken

Locations

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Stureplanskliniken

Gothenburg, , Sweden

Site Status

Akademikliniken

Malmo, , Sweden

Site Status

Stureplanskliniken

Stockholm, , Sweden

Site Status

Akademikliniken

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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31GB0902

Identifier Type: -

Identifier Source: org_study_id

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