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OpenTrials
Completed

NCT Number: NCT01609400

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

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.

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Key information

Conditions

Breast Enhancement

Age range

25 year–50 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subject treated with NASHA-gel in the breasts in study 31GB0607
  • signed informed consent

Exclusion criteria

  • no exclusion criteria in this study

Treatment and study plan

Primary outcomes

  1. Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI

    Time frame: 4 years

  2. Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI

    Time frame: 6 years

Secondary outcomes

  1. Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.

    Time frame: 4 years

  2. Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos

    Time frame: 4 years

  3. Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)

    Time frame: 4 years

  4. Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.

    Time frame: 6 years

  5. Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos

    Time frame: 6 years

  6. Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)

    Time frame: 6 years

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 1, 2012
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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