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

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ClinicalTrials.gov Identifier: NCT01609400
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Brief Summary:
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.

Condition or disease
Breast Enhancement

Study Type : Observational
Actual Enrollment : 11 participants
Time Perspective: Prospective
Study Start Date : December 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Group/Cohort
Breast enhancement



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects treated in study 31GB0607
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteria in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609400


Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Per Hedén, M.D. Akademikliniken, Stockholm, Sweden
Principal Investigator: Michael Olenius, M.D. Proforma Clinic AB, Stockholm, Sweden

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01609400     History of Changes
Other Study ID Numbers: 31GB1103
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015