An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast

NCT ID: NCT01609400

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

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-08-31

Brief Summary

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The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.

Detailed Description

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Conditions

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Breast Enhancement

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast enhancement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* subject treated with NASHA-gel in the breasts in study 31GB0607
* signed informed consent
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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, M.D.

Role: PRINCIPAL_INVESTIGATOR

Akademikliniken, Stockholm, Sweden

Michael Olenius, M.D.

Role: PRINCIPAL_INVESTIGATOR

Proforma Clinic AB, Stockholm, Sweden

Other Identifiers

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31GB1103

Identifier Type: -

Identifier Source: org_study_id

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