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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01308853
First received: February 22, 2011
Last updated: May 31, 2012
Last verified: February 2011
  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
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 ]

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

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
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: 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

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01308853     History of Changes
Other Study ID Numbers: 31GB0607
Study First Received: February 22, 2011
Last Updated: May 31, 2012
Health Authority: Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on July 24, 2014