Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast (COBRA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01299532
First received: February 16, 2011
Last updated: November 8, 2013
Last verified: February 2011
  Purpose

This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.


Condition Intervention Phase
Breast Enhancement
Device: Macrolane VRF30
Phase 4

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 Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • to study the implant duration and localization as documented by MRI. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • to evaluate pain experience during injection under local anesthesia. [ Time Frame: during injection ] [ Designated as safety issue: No ]
  • To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment. [ Time Frame: 39 months ] [ Designated as safety issue: Yes ]
  • Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment). [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
  • Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia. [ Time Frame: During re-injection ] [ Designated as safety issue: Yes ]
  • Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: November 2008
Study Completion Date: October 2013
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macrolane VRF30 Device: Macrolane VRF30
Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria:

  • Unreasonable expectations as regards the increase in breast volume
  • Any medical conditions that may interfere in any way.
  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: NCT01299532

Locations
France
L'Institute du Sein
Paris, France, 75116
Sainte Anne
Paris, France, 75014
Sweden
Akademikliniken
Stockholm, Sweden, 115 42
Plastikkirurggruppen
Stockholm, Sweden, 113 24
Proforma Clinic
Stockholm, Sweden, 118 63
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Per Hedén, M.D., Ph.D. Akademikliniken, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01299532     History of Changes
Other Study ID Numbers: 31GB0801
Study First Received: February 16, 2011
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on November 20, 2014