NASHA BE for Enhancement of the Shape and Fullness of the Female Breast (COBRA)
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|ClinicalTrials.gov Identifier: NCT01308853|
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : June 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Enhancement||Device: NASHA BE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|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|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||May 2010|
- Device: NASHA BE
Device: NASHA BE (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast.
- 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.
- 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 ]
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
|Principal Investigator:||Per Hedén, M.D.||Akademikliniken, Stockholm, Sweden|
|Principal Investigator:||Michael Olenius, M.D.||Proforma Clinic AB, Stockholm, Sweden|