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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01609400
First received: May 8, 2012
Last updated: May 30, 2012
Last verified: June 2011
History of Changes
  Purpose

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
Breast Enhancement

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast enhancement

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01609400     History of Changes
Other Study ID Numbers: 31GB1103
Study First Received: May 8, 2012
Last Updated: May 30, 2012
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on May 16, 2013