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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01609400
First received: May 8, 2012
Last updated: November 8, 2013
Last verified: November 2013
  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:


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 ]

Enrollment: 11
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 8, 2013
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on July 22, 2014