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NASHA BE for Enhancement of the Shape and Fullness of the Female Breast (COBRA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308853
First Posted: March 4, 2011
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Q-Med AB
  Purpose
The study evaluates treatment procedure, efficacy and safety of NASHA BE for female breast enhancement.

Condition Intervention Phase
Breast Enhancement Device: NASHA BE Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open, Multi-center Study Evaluating Treatment Procedure, Efficacy and Safety of NASHA BE for Enhancement of the Shape and Fullness of Teh Female Breast

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • The primary objective is to develop an injection technique for placement of the implant posterior to the mammary gland. This will be documented through MRI 1-5 days after the injection and evaluated by the Expert Group 6 weeks after treatment.
    Inclusion was made in steps, each step incl. treatment of 2 subjects at each of the 2 sites (1 group). The subjects were followed-up with MRI 1-5 days after the injection. Before the next group of 4 subjects were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.The aim of the step-wise inclusion was to refine the injection procedure through implant placement assessment, and to evaluate safety and the esthetic results prior to treating the next group.


Secondary Outcome Measures:
  • Assess the safety at 6 weeks through physical examination, reported adverse events (AEs) and Adverse Experiences reported in a diary during 2 weeks post treatment. [ Time Frame: 2 weeks ]
  • evaluate esthetic improvement at 6 weeks as judged by the investigator using GEIS [ Time Frame: 6 weeks ]
  • evaluate pain experienced during injection under local anesthesia
  • assess if inflammatory response is elicited by the implant, using blood sample analysis and body temperature (first 8 treated patients only)
  • assess if the gel can be detected and delineated from surrounding tissues by mammography as evaluated and commented by the radiologist 12 months after treatment.
  • assess the safety as documented by physical examination and by AEs reported up to 24 months. [ Time Frame: 24 months ]
  • evaluate, at 12 months, in 4 subjects, any implant damage or displacement caused by compression of the breast in conjunction with mammographic investigation using MRI [ Time Frame: 12 months ]
  • evaluate the esthetic improvement as judged by an independent evaluator, by the investigator and by the subject using GEIS, up to 24 months. [ Time Frame: 24 months ]
  • evaluate, up to 24 months, the subjects satisfaction with her breast and general appearance using a questionnaire. [ Time Frame: 24 months ]

Enrollment: 24
Study Start Date: March 2007
Study Completion Date: May 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NASHA BE
    Device: NASHA BE (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria:

  • Unreasonable expectations
  • Any medical condition that may interfere with the treatment
  Contacts and Locations
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): NCT01308853


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

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01308853     History of Changes
Other Study ID Numbers: 31GB0607
First Submitted: February 22, 2011
First Posted: March 4, 2011
Last Update Posted: June 1, 2012
Last Verified: February 2011