NASHA BE for Enhancement of the Shape and Fullness of the Female Breast (COBRA)
This study has been completed.
Information provided by (Responsible Party):
First received: February 22, 2011
Last updated: May 31, 2012
Last verified: February 2011
The study evaluates treatment procedure, efficacy and safety of NASHA BE for female breast enhancement.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- evaluate esthetic improvement at 6 weeks as judged by the investigator using GEIS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- evaluate pain experienced during injection under local anesthesia [ Designated as safety issue: No ]
- assess if inflammatory response is elicited by the implant, using blood sample analysis and body temperature (first 8 treated patients only) [ Designated as safety issue: Yes ]
- 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. [ Designated as safety issue: Yes ]
- assess the safety as documented by physical examination and by AEs reported up to 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- evaluate, up to 24 months, the subjects satisfaction with her breast and general appearance using a questionnaire. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Device: NASHA BE
Device: NASHA BE (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast.
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