Swedish Macrolane Registry

NCT ID: NCT01145235

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2019-01-31

Brief Summary

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A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.

Detailed Description

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Conditions

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Breast Augmentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Females previously treated with Macrolane in their breasts.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Females previously treated with Macrolane VRF in the breasts
2. Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment.
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

Locations

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Dr Per Hedén

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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31GB0905

Identifier Type: -

Identifier Source: org_study_id

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